Coronary Artery DiseasePhase 4PLATIDE-PCINCT02748330

Platelet Inhibition of Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients After Elective Percutaneous Coronary Intervention

A Phase 4 study testing Ticagrelor, Clopidogrel and Aspirin in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Diabetes Mellitus, Type 2
What is being tested?: Ticagrelor, Clopidogrel and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: Jun 2016to 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

Provision of written informed consent (by patient or appropriate designee according to local regulations) prior to any study specific procedures.
Aged 18 years or older, male or female.
Documented stable coronary artery disease (CAD) fulfilling any of the following:
History of stable angina pectoris with angiographic evidence of CAD (diameter stenosis ≥ 50%) in major, i.e., left main, left anterior descending, left circumflex, and right coronary arteries.
History of previous myocardial infarction (MI)
History of coronary revascularization, i.e., percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG), not including the elective PCI during the index hospitalization

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Documented history of type 2 diabetes mellitus.
At least 24 hours after but within 14 days of angiographically successful elective PCI without complications.
Post-procedural residual diameter stenosis of the treated lesions < 20% in patients with stent implantation or < 50% in those with balloon angioplasty
Post-procedural thrombolysis in myocardial infarction (TIMI) grade 3 flow in treated vessels
Negative cardiac troponin test before the index elective PCI.
Taking Clopidogrel 75 mg daily dose for at least 7 days or taking Clopidogrel 75 mg daily dose for less than 7 days but with 300 to 600 mg Clopidogrel loading dose before PCI.
Taking acetylsalicylic acid (ASA) 100 mg daily treatment for at least 7 days or taking ASA 100 mg daily dose for less than 7 days but with 300 mg ASA loading dose before PCI.
Females with childbearing potential (i.e., females who are not post-menopausal or surgically sterile) must:
have a negative urine or blood pregnancy test at enrolment and prior to randomization;
currently be using a hormonal contraceptive and agree to continue its use in addition to using double-barrier local contraception (i.e., intra-uterine device plus spermicidal and condom for male partner) from screening through study completion.

Who cannot join

Patients who had acute coronary syndrome (ACS) within 12 months of screening.
Occurrence of myocardial infarction (MI) related to index elective PCI (type 4a MI) or myocardial infarction related to stent thrombosis (type 4b MI) according to the Third Universal Definition of Myocardial Infarction.
Use of parenteral antithrombotic agents, e.g., glycoprotein IIb/IIIa inhibitors (GPIs), bivalirudin, unfractionated heparin, enoxaparin or fondaparinux within 24 hours of screening.
Use of any oral antithrombotic agents, with the exception of Clopidogrel and ASA, within 30 days of screening.
Any other indications (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for antithrombotic treatment other than ASA 100 mg daily, Clopidogrel and Ticagrelor during study period.
Concomitant therapy with moderate or strong cytochrome P-450 (CYP) 3A inhibitors, CYP 3A substrates with narrow therapeutic index, or strong CYP 3A inducers during study period.

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Concomitant therapy with moderate or strong CYP 2C19 inhibitors, CYP 2C19 substrates with narrow therapeutic index, or strong CYP 2C19 inducers during study period.
Increased bleeding risk including:
recent (within 30 days of screening) gastrointestinal (GI) bleeding;
any history of intracranial, intraocular, retroperitoneal, or spinal bleeding;
recent (within 30 days of screening) major trauma or major surgery;
sustained uncontrolled hypertension (systolic blood pressure [SBP] > 180 mmHg or diastolic blood pressure [DBP] > 100 mmHg);
history of hemorrhagic disorders that can increase the risk of bleeding, e.g., haemophilia, von Willebrand's disease;
inability to discontinue required concomitant therapy with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) at screening;
platelet count less than 100,000/mm3 or hemoglobin < 10 g/dL.
Contraindication or other reason that ASA, Clopidogrel, or Ticagrelor should not be administered (e.g., hypersensitivity, active bleeding [including active pathological bleeding], any bleeding tendency [coagulation defects], moderate and severe hepatic impairment, risk of bradycardia, chronic obstructive pulmonary disease, chronic or active asthma, hyperuricemia, gout, etc.).
History of intolerance to ASA, Clopidogrel or Ticagrelor.
Patients that are scheduled for CABG during the study period.
Patient requires dialysis or has a creatinine clearance (Clcr) < 30 mL/min as calculated by the Cockcroft-Gault equation: Clcr = (140 - Age) × WT / (72 × Scr) (× 0.85 for females), where WT is weight in kg, Scr is serum creatinine in mg/dL.
Any acute or chronic unstable conditions in the past 30 days or other conditions which, in the opinion of the investigator, may either put the patient at risk or influence the result of the study (e.g., active cancer, risk for non-compliance, risk for being lost to follow-up).
Participation in another investigational drug or device study within 30 days of screening.
Involvement in the planning and conduct of the study (applies to investigators, contract research organization staff, and study site staff).
History of drug addiction or alcohol abuse in the previous 2 years.
Recent (within 30 days of screening) blood donation.
Known pregnancy, breast-feeding, or intend to become pregnant during the study period.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coronary Intervention

This will be a single-center, randomized, open-label, active-controlled, parallel-group study to investigate the platelet inhibition of Ticagrelor versus Clopidogrel with acetylsalicylic acid (ASA) as background therapy in approximate 40 patients with stable coronary artery disease (SCAD) and type 2 diabetes mellitus (DM) after recent successful elective percutaneous coronary intervention (PCI) by evaluation of the P2Y12 reaction unit (PRU) by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on treatment day 15±2.

Read the detailed description

The study will consist of a screening period, a 15±2 day treatment period, and a 7 day follow-up period. The screening period will be up to 7 days. Once each patient has signed the informed consent, the eligibility of the patient will be determined at screening, and laboratory assessments will be taken (Visit 1). During the treatment period, patients participating in the study will be randomized to receive either Ticagrelor with ASA, or Clopidogrel with ASA for 15±2 days. The final dose of study medication will be administered at the study site in the morning of day 15±2. Study visits at the beginning (Visit 2) and the end of the treatment period (Visit 4) will allow assessment of platelet function. At 7±1 days after Visit 2, a telephone visit (Visit 3) will be carried out for collection of information on concomitant medication, adverse events (including vascular events), and safety end point events. After the platelet function tests at Visit 4 are finished, patients in both groups will discontinue their study medication (end of treatment, EOT). A follow-up period will begin at 1 day after Visit 4 and continue for 7 days. During the follow-up period, patients in Ticagrelor group will take Clopidogrel 600 mg loading dose on the first day, followed by Clopidogrel 75 mg maintenance dose from the second day for 6 days; patients in Clopidogrel group will continue taking Clopidogrel 75 mg maintenance dose for 7 days. Both adverse events (including vascular events) and safety end point events will be collected at the safety visit (Visit 5), which will occur 7 days after Visit 4. The study will last approximately 4 weeks per patient. After the informed consents are signed by the patients, all adverse events (including vascular events), safety end point events and concomitant medications will be recorded at each visit.

Conditions: Coronary Artery Disease, Diabetes Mellitus, Type 2
Being tested: Ticagrelor, Clopidogrel, Aspirin
Medical subject headings: Coronary Artery Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TicagrelorDrug
Also called Brilinta
Ticagrelor
ClopidogrelDrug
Also called Plavix
Clopidogrel
AspirinDrug
Acetylsalicylic acid

Study groups in NCT02748330
Study group	Role	What they receive
Ticagrelor	Experimental	Oral ticagrelor 90 mg tablet, twice daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days Receives: Drug: Ticagrelor; Drug: Aspirin
Clopidogrel	Active comparator	Oral clopidogrel 75 mg tablet, once daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days Receives: Drug: Clopidogrel; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

P2Y12 reaction unit (PRU)
The PRU by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2
Measured: 15±2 days

Secondary outcomes (8)

P2Y12 reaction unit (PRU) (before)
The PRU by VerifyNow P2Y12 assay before the first study drug dose on day 15±2
Measured: 15±2 days
Percent inhibition (% Inhibition)
The % Inhibition by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2
Measured: 15±2 days
Percent inhibition (% Inhibition) (before)
The % Inhibition by VerifyNow P2Y12 assay before the first study drug dose on day 15±2
Measured: 15±2 days
High on-treatment platelet reactivity (HOPR)
The rate of HOPR by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2
Measured: 15±2 days
High on-treatment platelet reactivity (HOPR) (before)
The rate of HOPR by VerifyNow P2Y12 assay before the first study drug dose on day 15±2
Measured: 15±2 days
Non-coronary artery bypass graft (CABG) related major bleeding
The rate of non-CABG related major bleeding according to Platelet Inhibition and Patient Outcome (PLATO) study definition up to day 15±2.
Measured: 15±2 days
Non-coronary artery bypass graft (CABG) related major or minor bleeding
The rate of non-CABG related major or minor bleeding according to PLATO definition up to day 15±2.
Measured: 15±2 days
Non-coronary artery bypass graft (CABG) related major or minor or minimal bleeding
The rate of non-CABG related major or minor or minimal bleeding according to PLATO definition up to day 15±2.
Measured: 15±2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Dec 2018

First posted22 Apr 2016 (estimated)
Study startJun 2016
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (57)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe 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
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02748330
Sponsor's protocol ID: HS-873
Other IDs: ESR-14-10403
Acronym: PLATIDE-PCI
Status last verified: Dec 2017
First submitted: 19 Apr 2016
Last updated: 21 Mar 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Ramirez C, Sabate M, Jimenez-Quevedo P, Hernandez R, Moreno R, Escaned J, Alfonso F, Banuelos C, Costa MA, Bass TA, Macaya C. Platelet function profiles in patients with type 2 diabetes and coronary artery disease on combined aspirin and clopidogrel treatment. Diabetes. 2005 Aug;54(8):2430-5. doi: 10.2337/diabetes.54.8.2430.
PubMed 16046311
Angiolillo DJ, Bernardo E, Sabate M, Jimenez-Quevedo P, Costa MA, Palazuelos J, Hernandez-Antolin R, Moreno R, Escaned J, Alfonso F, Banuelos C, Guzman LA, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of platelet reactivity on cardiovascular outcomes in patients with type 2 diabetes mellitus and coronary artery disease. J Am Coll Cardiol. 2007 Oct 16;50(16):1541-7. doi: 10.1016/j.jacc.2007.05.049. Epub 2007 Oct 1.
PubMed 17936152
Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, Costa MA. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007 Apr 10;49(14):1505-16. doi: 10.1016/j.jacc.2006.11.044. Epub 2007 Mar 26.
PubMed 17418288
Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
PubMed 17261652
Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.
PubMed 11786451
Antithrombotic Trialists' (ATT) Collaboration; Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.
PubMed 19482214
Arnold SV, Morrow DA, Lei Y, Cohen DJ, Mahoney EM, Braunwald E, Chan PS. Economic impact of angina after an acute coronary syndrome: insights from the MERLIN-TIMI 36 trial. Circ Cardiovasc Qual Outcomes. 2009 Jul;2(4):344-53. doi: 10.1161/CIRCOUTCOMES.108.829523. Epub 2009 Jun 2.
PubMed 20031860
Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.
PubMed 12020339
Caiazzo G, De Rosa S, Torella D, Spaccarotella C, Mongiardo A, Giampa S, Micieli M, Palella E, Gulletta E, Indolfi C. Administration of a loading dose has no additive effect on platelet aggregation during the switch from ongoing clopidogrel treatment to ticagrelor in patients with acute coronary syndrome. Circ Cardiovasc Interv. 2014 Feb;7(1):104-12. doi: 10.1161/CIRCINTERVENTIONS.113.000512. Epub 2014 Jan 21.
PubMed 24449597
Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010 Jan 23;375(9711):283-93. doi: 10.1016/S0140-6736(09)62191-7. Epub 2010 Jan 13.
PubMed 20079528
Colwell JA, Nesto RW. The platelet in diabetes: focus on prevention of ischemic events. Diabetes Care. 2003 Jul;26(7):2181-8. doi: 10.2337/diacare.26.7.2181.
PubMed 12832332
Creager MA, Luscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part I. Circulation. 2003 Sep 23;108(12):1527-32. doi: 10.1161/01.CIR.0000091257.27563.32. No abstract available.
PubMed 14504252
Davies SL. Ticagrelor. Drugs Today (Barc). 2010 Apr;46(4):243-50. doi: 10.1358/dot.2010.46.4.1467168.
PubMed 20502721
Diodati JG, Saucedo JF, French JK, Fung AY, Cardillo TE, Henneges C, Effron MB, Fisher HN, Angiolillo DJ. Effect on platelet reactivity from a prasugrel loading dose after a clopidogrel loading dose compared with a prasugrel loading dose alone: Transferring From Clopidogrel Loading Dose to Prasugrel Loading Dose in Acute Coronary Syndrome Patients (TRIPLET): a randomized controlled trial. Circ Cardiovasc Interv. 2013 Oct 1;6(5):567-74. doi: 10.1161/CIRCINTERVENTIONS.112.000063. Epub 2013 Sep 24.
PubMed 24065443
Ferreira IA, Eybrechts KL, Mocking AI, Kroner C, Akkerman JW. IRS-1 mediates inhibition of Ca2+ mobilization by insulin via the inhibitory G-protein Gi. J Biol Chem. 2004 Jan 30;279(5):3254-64. doi: 10.1074/jbc.M305474200. Epub 2003 Nov 5.
PubMed 14602724

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Active-controlled, Parallel-group Study to Investigate the Platelet Inhibition of Ticagrelor Versus Clopidogrel in Patients With Stable Coronary Artery Disease and Type 2 Diabetes Mellitus After Recent Elective Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT02748330
Acronym / sponsor ID: PLATIDE-PCI / HS-873
Conditions: Coronary Artery Disease, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: Jun 2016
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 22 Apr 2016 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ticagrelor	Experimental	Drug: Ticagrelor, Drug: AspirinOral ticagrelor 90 mg tablet, twice daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days
Clopidogrel	Active comparator	Drug: Clopidogrel, Drug: AspirinOral clopidogrel 75 mg tablet, once daily for 15±2 days. Oral aspirin 100 mg tablet, once daily for 15±2 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Provision of written informed consent (by patient or appropriate designee according to local regulations) prior to any study specific procedures.
Aged 18 years or older, male or female.
Documented stable coronary artery disease (CAD) fulfilling any of the following:
Documented history of type 2 diabetes mellitus.
At least 24 hours after but within 14 days of angiographically successful elective PCI without complications.

Key exclusion criteria (25 listed)

Patients who had acute coronary syndrome (ACS) within 12 months of screening.
Occurrence of myocardial infarction (MI) related to index elective PCI (type 4a MI) or myocardial infarction related to stent thrombosis (type 4b MI) according to the Third Universal Definition of Myocardial Infarction.
Use of parenteral antithrombotic agents, e.g., glycoprotein IIb/IIIa inhibitors (GPIs), bivalirudin, unfractionated heparin, enoxaparin or fondaparinux within 24 hours of screening.
Use of any oral antithrombotic agents, with the exception of Clopidogrel and ASA, within 30 days of screening.
Any other indications (e.g., atrial fibrillation, prosthetic heart valve, venous thromboembolism, ventricular thrombosis, et al) for antithrombotic treatment other than ASA 100 mg daily, Clopidogrel and Ticagrelor during study period.

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
TicagrelorAlso: BrilintaTicagrelor	Drug	Ticagrelor
ClopidogrelAlso: PlavixClopidogrel	Drug	Clopidogrel
AspirinAcetylsalicylic acid	Drug	Clopidogrel, Ticagrelor

Primary outcome

P2Y12 reaction unit (PRU)
Time frame: 15±2 days
The PRU by VerifyNow P2Y12 assay at 2-4 hours after the first study drug dose on day 15±2

8 secondary outcomes

P2Y12 reaction unit (PRU) (before)
Time frame: 15±2 days
Percent inhibition (% Inhibition)
Time frame: 15±2 days
Percent inhibition (% Inhibition) (before)
Time frame: 15±2 days
High on-treatment platelet reactivity (HOPR)
Time frame: 15±2 days
High on-treatment platelet reactivity (HOPR) (before)
Time frame: 15±2 days
Non-coronary artery bypass graft (CABG) related major bleeding
Time frame: 15±2 days
Non-coronary artery bypass graft (CABG) related major or minor bleeding
Time frame: 15±2 days
Non-coronary artery bypass graft (CABG) related major or minor or minimal bleeding
Time frame: 15±2 days

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 21 Mar 2019.
Results publication: PubMed 16046311Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Ramirez C, Sabate M, Jimenez-Quevedo P, Hernandez R, Moreno R, Escaned J, Alfonso F, Banuelos C, Costa MA, Bass TA, Macaya C. Platelet function profiles in patients with type 2 diabetes and coronary artery disease on combined aspirin and clopidogrel treatment. Diabetes. 2005 Aug;54(8):2430-5. doi: 10.2337/diabetes.54.8.2430.
Results publication: PubMed 17936152Angiolillo DJ, Bernardo E, Sabate M, Jimenez-Quevedo P, Costa MA, Palazuelos J, Hernandez-Antolin R, Moreno R, Escaned J, Alfonso F, Banuelos C, Guzman LA, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of platelet reactivity on cardiovascular outcomes in patients with type 2 diabetes mellitus and coronary artery disease. J Am Coll Cardiol. 2007 Oct 16;50(16):1541-7. doi: 10.1016/j.jacc.2007.05.049. Epub 2007 Oct 1.
Results publication: PubMed 17418288Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, Costa MA. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007 Apr 10;49(14):1505-16. doi: 10.1016/j.jacc.2006.11.044. Epub 2007 Mar 26.
Results publication: PubMed 17261652Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. doi: 10.1161/CIRCULATIONAHA.106.667741. Epub 2007 Jan 29.
Results publication: PubMed 11786451Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.
Results publication: PubMed 19482214Antithrombotic Trialists' (ATT) Collaboration; Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.
Results publication: PubMed 20031860Arnold SV, Morrow DA, Lei Y, Cohen DJ, Mahoney EM, Braunwald E, Chan PS. Economic impact of angina after an acute coronary syndrome: insights from the MERLIN-TIMI 36 trial. Circ Cardiovasc Qual Outcomes. 2009 Jul;2(4):344-53. doi: 10.1161/CIRCOUTCOMES.108.829523. Epub 2009 Jun 2.
Results publication: PubMed 12020339Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.
Results publication: PubMed 24449597Caiazzo G, De Rosa S, Torella D, Spaccarotella C, Mongiardo A, Giampa S, Micieli M, Palella E, Gulletta E, Indolfi C. Administration of a loading dose has no additive effect on platelet aggregation during the switch from ongoing clopidogrel treatment to ticagrelor in patients with acute coronary syndrome. Circ Cardiovasc Interv. 2014 Feb;7(1):104-12. doi: 10.1161/CIRCINTERVENTIONS.113.000512. Epub 2014 Jan 21.
Results publication: PubMed 20079528Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, Wallentin L; PLATelet inhibition and patient Outcomes Investigators. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study. Lancet. 2010 Jan 23;375(9711):283-93. doi: 10.1016/S0140-6736(09)62191-7. Epub 2010 Jan 13.
Results publication: PubMed 12832332Colwell JA, Nesto RW. The platelet in diabetes: focus on prevention of ischemic events. Diabetes Care. 2003 Jul;26(7):2181-8. doi: 10.2337/diacare.26.7.2181.
Results publication: PubMed 14504252Creager MA, Luscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part I. Circulation. 2003 Sep 23;108(12):1527-32. doi: 10.1161/01.CIR.0000091257.27563.32. No abstract available.
Individual participant dataSharing planned: Undecided

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Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease

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.

Shuyang Zhang, M.D. principal investigator

Peking Union Medical College Hospital

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, Clopidogrel and Aspirin in people with Coronary Artery Disease and Diabetes Mellitus, Type 2, run by Peking Union Medical College Hospital 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 16 inclusion and 25 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 21 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?

P2Y12 reaction unit (PRU) (time frame: 15±2 days). 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 NCT02748330, which also lists 57 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 21 Mar 2019.