Acute Coronary SyndromePhase 4FMD_ACSNCT03881943
Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of ACS
A Phase 4 study testing Ticagrelor 60 mg and Aspirin 100 MG Oral Tablet, Enteric Coated in people with Acute Coronary Syndrome, run by The University of Hong Kong at 1 site in China.
Trial summary
Antiplatelet agents are cornerstones for management of ischemic heart disease. For patients suffering from acute coronary syndrome (heart attack), treatment with aspirin and ticagrelor are typically given for one year after index heart attack and then patients will continue to take aspirin lifelong. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor 60 mg and Aspirin 100 MG Oral Tablet, Enteric Coated
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to 21 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or above.
- Documented history of presumed spontaneous ACS (excluding known peri-procedural or definite secondary MI [eg, due to profound hypotension, hypertensive emergency, tachycardia, or profound anemia]) with their most recent MI occurring 18 months or more prior to randomization
- Patient currently prescribed and tolerating ASA
- Females of child-bearing potential (ie, who are not chemically or surgically sterilized or who are not post-menopause) must have a negative urine pregnancy test at enrollment (to be confirmed by blood pregnancy test at the central lab.) Females of child-bearing potential must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator.
- Written informed consent prior to any study specific procedures.
Who cannot join
- Recurrent cardiovascular event (ACS, stroke and unplanned revascularization) after the index ACS
- Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol
- Planned coronary, cerebrovascular, or peripheral arterial revascularization
- Concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study - Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice - Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily
- Concomitant use of vasoactive drugs or vasoactive drugs cannot be stopped.
- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
Show all 26Show fewer
- Patients with known bleeding diathesis or coagulation disorder
- Patients with:
- Concomitant active pathological bleeding,
- A history of intracranial bleed at any time,
- A central nervous system tumour or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time,
- Intracranial or spinal cord surgery within 5 years, or
- A gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days
- History of ischemic stroke at any time
- Patients considered to be at risk of bradycardic events ([eg, known sick sinus syndrome or second or third degree atrioventricular (AV) block]) unless already treated with a permanent pacemaker
- Coronary-artery bypass grafting in the past 5 years, unless the patient has experienced a spontaneous MI subsequent to the bypass surgery.
- Known severe liver disease (eg, ascites or signs of coagulopathy)
- Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- Hypersensitivity to ticagrelor or any excipients
- Pregnancy or lactation
- Life expectancy < 1 year
- Any condition which in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer)
- Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
- Participation in previous study with ticagrelor if treated with ticagrelor. Previous randomization in the present study
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Participation in another clinical study with an investigational product during the preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Center Trial to Assess the Endothelial Function With Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of Acute Coronary Syndrome
Antiplatelet agents are cornerstones for management of ischemic heart disease. For patients suffering from acute coronary syndrome (heart attack), treatment with aspirin and ticagrelor are typically given for one year after index heart attack and then patients will continue to take aspirin lifelong. However, these patients are still having increased risk of suffering from another heart attack. Recently data showed that adding ticagrelor to aspirin in the long term can decrease the chance of recurrent heart attack but at the cost of increased risk of major bleeding. On the other hand, ticagrelor is a potent antiplatelet agent and has been showed to have additional benefit on blood vessels and platelets. The investigator hypothesize that monotherapy with ticagrelor may have further benefit over monotherapy with aspirin in the long term management in patients with history of heart attack. The investigator plan to perform a randomized study to compare the outcome in patients taking either ticagrelor or aspirin. The primary endpoint is measurement of endothelial function by flow mediated dilatation of brachial artery which is a surrogate marker of adverse cardiovascular outcome 3 months after treatment. The investigator would also investigate secondary endpoints of patients' blood level of adenosine activity, platelet function, endothelial progenitor cell count and biomarkers
Read the detailed description
Acute coronary syndrome (ACS) is a disease with high mortality, morbidity and economic burden. Usually, it is caused by ischemic heart disease and atherosclerotic plaque rupture in the coronary arteries causing platelet activation, aggregation and thrombus formation. For decades, antiplatelet agents are the cornerstones of management of ACS and several clinical trials have confirmed greater clinical efficacy of dual antiplatelet therapy with clopidogrel and aspirin (ASA) versus ASA alone in patients with acute coronary syndromes (ACS) for up to a year of therapy. Ticagrelor (AZD6140) is a reversible, potent, oral adenosine diphosphate (ADP) P2Y12 receptor blocker which has stronger antiplatelet activity than clopidogrel. Data from PLATO, a Phase III pivotal efficacy and safety study of ticagrelor, have demonstrated superiority of ticagrelor 90 mg twice daily over clopidogrel 75 mg daily with a duration of up to 12 months in the prevention of fatal and non-fatal cardiovascular event in ACS patients on ASA.
In PLATO, ticagrelor was superior to clopidogrel in reducing the rate of the composite efficacy endpoint of CV death, MI, or stroke after ACS events. Furthermore, compared to clopidogrel, ticagrelor decreased the rate of death from any cause. PLATO-defined Major bleeding (primary safety endpoint) for ticagrelor did not differ significantly from that of clopidogrel but ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting.
The favourable results lead to approval of use of ticagrelor as Class I indication in ACS patients for up to one year in addition to ASA in ACC/AHA and European guidelines. After one year of DAPT, patients typically remained on single antiplatelet agent with ASA monotherapy being the conventional treatment. However, these patients are still at heightened risk of recurrent atherothrombotic events. The recent PEGASUS TIMI 54 trial investigated the use of ticagrelor in addition to aspirin in stable patients with prior myocardial infarction one to three years ago. It demonstrated ticagrelor either 90mg BD or 60mg BD significantly reduced the risk of cardiovascular death, MI and stroke compared with placebo; ticagrelor 60mg BD. However, the use of ticagrelor is also associated with higher risks of major bleeding; ticagrelor 60mg BD, HR 2.32.
As the antithrombotic benefit of stronger antiplatelet effects of DAPT is offset by higher bleeding risk, it is reasonable to assume that a single potent antiplatelet agent such as ticagrelor may lead to better clinical outcome than ASA with less increase in bleeding risk when compared with DAPT. In addition to its antiplatelet effects, ticagrelor has been shown to improve endothelial function, increase plasma adenosine level, increase coronary blood flow, stabilize coronary plaques and reduce inflammation. These pleiotropic effects may lead to further clinical benefit of ticagrelor over other antiplatelet agents such as ASA and clopidogrel. Endothelial function as measured by flow mediated dilatation of brachial artery is a non-invasively measurable surrogate marker of adverse cardiovascular events. Adenosine is a purine nucleoside which has favourable effects on coronary vasodilatation, endothelial progenitor cell migration and ischemia-reperfusion injury while adenosine plasma activity can be measured by liquid chromatography.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor 60 mg, Aspirin 100 MG Oral Tablet, Enteric Coated
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 60 mgDrug
Also called Brilinta
Potent antiplatelet agent, 60mg twice daily for 3 months
Aspirin 100 MG Oral Tablet, Enteric CoatedDrug
Also called Cartia
antiplatelet agent, 100mg once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Active comparator | Ticagrelor 60mg BD for 3 months Receives: Drug: Ticagrelor 60 mg |
| Aspirin | Active comparator | Aspirin 100mg daily for 3 months Receives: Drug: Aspirin 100 MG Oral Tablet, Enteric Coated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
the flow mediated dilatation of brachial artery at baseline and 3 months after randomization. Demonstrate brachial diameters, the measurement will be presented in absolute FMD millimeter (FMDmm). The report value should be present in FMD percentage (FMD%) as the mean of baseline measurement minus the mean of 3 months measurement then divided by the 3 months measurement.
Measured: 3 months
Secondary outcomes (1)
Plasma adenosine level Platelet function parameters Endothelial progenitor cell count Biomarkers such as highly sensitive troponin
collect the blood sample to test the Plasma adenosine level Platelet function parameters Endothelial progenitor cell count Biomarkers such as highly sensitive troponin at baseline and 3 months after randomization. The unit of the test should be nmol/L
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study startJan 2017
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ticagrelor or Aspirin
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse Hung Fat, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881943
- Sponsor's protocol ID
- FMD_1.3
- Acronym
- FMD_ACS
- Status last verified
- Mar 2019
- First submitted
- 5 Mar 2019
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1607-21. doi: 10.1016/S0140-6736(05)67660-X.
PubMed 16271642Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
PubMed 11519503Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PubMed 19717846Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
PubMed 25773268Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.
PubMed 25249586Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
PubMed 21873419Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.
PubMed 24768873Inaba Y, Chen JA, Bergmann SR. Prediction of future cardiovascular outcomes by flow-mediated vasodilatation of brachial artery: a meta-analysis. Int J Cardiovasc Imaging. 2010 Aug;26(6):631-40. doi: 10.1007/s10554-010-9616-1. Epub 2010 Mar 26.
PubMed 20339920Ras RT, Streppel MT, Draijer R, Zock PL. Flow-mediated dilation and cardiovascular risk prediction: a systematic review with meta-analysis. Int J Cardiol. 2013 Sep 20;168(1):344-51. doi: 10.1016/j.ijcard.2012.09.047. Epub 2012 Oct 4.
PubMed 23041097Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.
PubMed 24291273Bhatt DL, Steg PG, Ohman EM, Hirsch AT, Ikeda Y, Mas JL, Goto S, Liau CS, Richard AJ, Rother J, Wilson PW; REACH Registry Investigators. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA. 2006 Jan 11;295(2):180-9. doi: 10.1001/jama.295.2.180.
PubMed 16403930Tam CF, Chan YH, Wong YK, Li Z, Zhu X, Su KJ, Ganguly A, Hwa K, Ling XB, Tse HF. Multi-Omics Signatures Link to Ticagrelor Effects on Vascular Function in Patients With Acute Coronary Syndrome. Arterioscler Thromb Vasc Biol. 2022 Jun;42(6):789-798. doi: 10.1161/ATVBAHA.121.317513. Epub 2022 Apr 7.
PubMed 35387483
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center Trial to Assess the Endothelial Function With Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03881943
- Acronym / sponsor ID
- FMD_ACS / FMD_1.3
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antiplatelet agents are cornerstones for management of ischemic heart disease. For patients suffering from acute coronary syndrome (heart attack), treatment with aspirin and ticagrelor are typically given for one year after index heart attack and then patients will continue to take aspirin lifelong. However, these patients are still having increased risk of suffering from another heart attack. Recently data showed that adding ticagrelor to aspirin in the long term can decrease the chance of recurrent heart attack but at the cost of increased risk of major bleeding. On the other hand, ticagrelor is a potent antiplatelet agent and has been showed to have additional benefit on blood vessels and platelets. The investigator hypothesize that monotherapy with ticagrelor may have further benefit over monotherapy with aspirin in the long term management in patients with history of heart attack. The investigator plan to perform a randomized study to compare the outcome in patients taking either ticagrelor or aspirin. The primary endpoint is measurement of endothelial function by flow mediated dilatation of brachial artery which is a surrogate marker of adverse cardiovascular outcome 3 months after treatment. The investigator would also investigate secondary endpoints of patients' blood level of adenosine activity, platelet function, endothelial progenitor cell count and biomarkers
Detailed description
Acute coronary syndrome (ACS) is a disease with high mortality, morbidity and economic burden. Usually, it is caused by ischemic heart disease and atherosclerotic plaque rupture in the coronary arteries causing platelet activation, aggregation and thrombus formation. For decades, antiplatelet agents are the cornerstones of management of ACS and several clinical trials have confirmed greater clinical efficacy of dual antiplatelet therapy with clopidogrel and aspirin (ASA) versus ASA alone in patients with acute coronary syndromes (ACS) for up to a year of therapy. Ticagrelor (AZD6140) is a reversible, potent, oral adenosine diphosphate (ADP) P2Y12 receptor blocker which has stronger antiplatelet activity than clopidogrel. Data from PLATO, a Phase III pivotal efficacy and safety study of ticagrelor, have demonstrated superiority of ticagrelor 90 mg twice daily over clopidogrel 75 mg daily with a duration of up to 12 months in the prevention of fatal and non-fatal cardiovascular event in ACS patients on ASA.
In PLATO, ticagrelor was superior to clopidogrel in reducing the rate of the composite efficacy endpoint of CV death, MI, or stroke after ACS events. Furthermore, compared to clopidogrel, ticagrelor decreased the rate of death from any cause. PLATO-defined Major bleeding (primary safety endpoint) for ticagrelor did not differ significantly from that of clopidogrel but ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting.
The favourable results lead to approval of use of ticagrelor as Class I indication in ACS patients for up to one year in addition to ASA in ACC/AHA and European guidelines. After one year of DAPT, patients typically remained on single antiplatelet agent with ASA monotherapy being the conventional treatment. However, these patients are still at heightened risk of recurrent atherothrombotic events. The recent PEGASUS TIMI 54 trial investigated the use of ticagrelor in addition to aspirin in stable patients with prior myocardial infarction one to three years ago. It demonstrated ticagrelor either 90mg BD or 60mg BD significantly reduced the risk of cardiovascular death, MI and stroke compared with placebo; ticagrelor 60mg BD. However, the use of ticagrelor is also associated with higher risks of major bleeding; ticagrelor 60mg BD, HR 2.32.
As the antithrombotic benefit of stronger antiplatelet effects of DAPT is offset by higher bleeding risk, it is reasonable to assume that a single potent antiplatelet agent such as ticagrelor may lead to better clinical outcome than ASA with less increase in bleeding risk when compared with DAPT. In addition to its antiplatelet effects, ticagrelor has been shown to improve endothelial function, increase plasma adenosine level, increase coronary blood flow, stabilize coronary plaques and reduce inflammation. These pleiotropic effects may lead to further clinical benefit of ticagrelor over other antiplatelet agents such as ASA and clopidogrel. Endothelial function as measured by flow mediated dilatation of brachial artery is a non-invasively measurable surrogate marker of adverse cardiovascular events. Adenosine is a purine nucleoside which has favourable effects on coronary vasodilatation, endothelial progenitor cell migration and ischemia-reperfusion injury while adenosine plasma activity can be measured by liquid chromatography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Ticagrelor or Aspirin
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Active comparator | Drug: Ticagrelor 60 mgTicagrelor 60mg BD for 3 months |
| Aspirin | Active comparator | Drug: Aspirin 100 MG Oral Tablet, Enteric CoatedAspirin 100mg daily for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 years or above.
- Documented history of presumed spontaneous ACS (excluding known peri-procedural or definite secondary MI [eg, due to profound hypotension, hypertensive emergency, tachycardia, or profound anemia]) with their most recent MI occurring 18 months or more prior to randomization
- Patient currently prescribed and tolerating ASA
- Females of child-bearing potential (ie, who are not chemically or surgically sterilized or who are not post-menopause) must have a negative urine pregnancy test at enrollment (to be confirmed by blood pregnancy test at the central lab.) Females of child-bearing potential must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator.
- Written informed consent prior to any study specific procedures.
Key exclusion criteria (26 listed)
- Recurrent cardiovascular event (ACS, stroke and unplanned revascularization) after the index ACS
- Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol
- Planned coronary, cerebrovascular, or peripheral arterial revascularization
- Concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study - Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice - Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily
- Concomitant use of vasoactive drugs or vasoactive drugs cannot be stopped.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 60 mgAlso: BrilintaPotent antiplatelet agent, 60mg twice daily for 3 months | Drug | Ticagrelor |
| Aspirin 100 MG Oral Tablet, Enteric CoatedAlso: Cartiaantiplatelet agent, 100mg once daily for 3 months | Drug | Aspirin |
Primary outcome
Endothelial Function
Time frame: 3 months
the flow mediated dilatation of brachial artery at baseline and 3 months after randomization. Demonstrate brachial diameters, the measurement will be presented in absolute FMD millimeter (FMDmm). The report value should be present in FMD percentage (FMD%) as the mean of baseline measurement minus the mean of 3 months measurement then divided by the 3 months measurement.
1 secondary outcome
Plasma adenosine level Platelet function parameters Endothelial progenitor cell count Biomarkers such as highly sensitive troponin
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Results publication: PubMed 16271642Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1607-21. doi: 10.1016/S0140-6736(05)67660-X.
- Results publication: PubMed 11519503Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
- Results publication: PubMed 19717846Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Results publication: PubMed 25773268Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.
- Results publication: PubMed 25249586Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.
- Results publication: PubMed 21873419Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.
- Results publication: PubMed 24768873Cattaneo M, Schulz R, Nylander S. Adenosine-mediated effects of ticagrelor: evidence and potential clinical relevance. J Am Coll Cardiol. 2014 Jun 17;63(23):2503-2509. doi: 10.1016/j.jacc.2014.03.031. Epub 2014 Apr 23.
- Results publication: PubMed 20339920Inaba Y, Chen JA, Bergmann SR. Prediction of future cardiovascular outcomes by flow-mediated vasodilatation of brachial artery: a meta-analysis. Int J Cardiovasc Imaging. 2010 Aug;26(6):631-40. doi: 10.1007/s10554-010-9616-1. Epub 2010 Mar 26.
- Results publication: PubMed 23041097Ras RT, Streppel MT, Draijer R, Zock PL. Flow-mediated dilation and cardiovascular risk prediction: a systematic review with meta-analysis. Int J Cardiol. 2013 Sep 20;168(1):344-51. doi: 10.1016/j.ijcard.2012.09.047. Epub 2012 Oct 4.
- Results publication: PubMed 24291273Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.
- Results publication: PubMed 16403930Bhatt DL, Steg PG, Ohman EM, Hirsch AT, Ikeda Y, Mas JL, Goto S, Liau CS, Richard AJ, Rother J, Wilson PW; REACH Registry Investigators. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA. 2006 Jan 11;295(2):180-9. doi: 10.1001/jama.295.2.180.
- Derived from this study: PubMed 35387483Tam CF, Chan YH, Wong YK, Li Z, Zhu X, Su KJ, Ganguly A, Hwa K, Ling XB, Tse HF. Multi-Omics Signatures Link to Ticagrelor Effects on Vascular Function in Patients With Acute Coronary Syndrome. Arterioscler Thromb Vasc Biol. 2022 Jun;42(6):789-798. doi: 10.1161/ATVBAHA.121.317513. Epub 2022 Apr 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor 60 mg and Aspirin 100 MG Oral Tablet, Enteric Coated in people with Acute Coronary Syndrome, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881943, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.