Acute ST Segment Elevation Myocardial InfarctionPhase 4TACATNCT02048085
Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute ST Segment Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Medical Center of South Arkansas at 1 site in United States.
Trial summary
This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the "Heart attack" in rural health center where access to cardiac… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2014to Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 to 75 years of age
- Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization
- ST-segment elevation of at least 0.1 mV in at least two contiguous limb leads, ST-segment elevation of at least 0.2 mV in at least two contiguous precordial leads, or left bundle-branch block that was not known to be old
- Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours
Who cannot join
- Hypersensitivity to ticagrelor or clopidogrel
- Active Pathological Bleeding or history of intracranial bleeding
- Concomitant use of oral anticoagulant
- Concomitant use of 40 mg of Simvastatin or lovastatin
- Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir
- Concomitant use of CYP2C19 inhibitors such as omeprazole or esomeprazole
Show all 12Show fewer
- Patients planned to urgent CABG
- Thrombocytopenia
- Dialysis
- Use of oral antiplatelet agent (ticagrelor, prasugrel, Clopidogrel) within 7 days prior to enrollment
- Use of GP IIb/IIIa inhibitors
- Rescue PCI (PCI < 24 hours from symptom onset) -
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of South Arkansas
El Dorado, Arkansas, 71730
About this study
Official title: A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours
This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the "Heart attack" in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials. In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs (Pharmacokinetics).
Read the detailed description
This is an open label randomized pharmacodynamics study to compare platelet function reactivity of ticagrelor and clopidogrel after PCI in sub-set of patients who have undergone fibrinolysis at least 24 hour prior to PCI..A total of 70 patients will be enrolled. Prior to enrollment, patients have already undergone fibrinolysis (selected by the treating physician), aspirin (recommended dose 324 mg) on the first day and 81 mg daily thereafter, and Lovenox or heparin as per protocol of referring ER. Patients will undergo coronary angiography as standard of care and coronary stenting if indicated. Prior to angiography patient will be enrolled in this open label randomized protocol to receive clopidogrel or ticagrelor. Patients will be randomly assigned in a 1:1 ratio by open label study to receive either clopidogrel (Plavix, Sanofi-Aventis and Bristol-Myers Squibb; a 300-mg loading dose followed by 75 mg once daily) or ticagrelor (Brilinta, AstraZeneca; 180 mg loading and 90 mg twice daily) by a computerized system of randomization. Patients will receive clopidogrel or ticagrelor daily from enrollment to discharge. For patients who did not undergo PCI after enrollment, study drugs will be administered up to and including day 8th or hospital discharge, whichever comes first. Patients will be treated as per standard of care, and pharmacodynamics and pharmacokinetic study will be carried as per protocol. VerifyNow and VASP assay will be used to measure platelet reactivity for pharmacodynamic evaluation of ticagrelor vs Clopidogrel at specific time points: baseline (time 0), 30 mins, 1 hour, 2 hours, 8 hours and at 24 hours from first oral anti-platelet dose.. Blood will be collected from the sheath or ante-cubital vein into Vacutainer tubes for platelet function assay as below by VerifyNow and VASP. VerifyNow P2Y12 Assay: VerifyNow is a turbidimetric based system that measures platelet aggregation in the whole blood.8 This instrument measures an optical signal reported as P2Y12 Reaction Units (PRU). Vasodilator-Stimulated Phosphoprotein Phosphrylation (VASP) Assay: The measure of Vasodilator-Stimulated Phosphoprotein Phosphrylation (Biocytex Inc. Marseille, France), a method to quantify P2Y12 receptor reactivity, which reflects the extent of blockade of P2Y12 receptor blockade.9 Platelet reactivity index (PRI) is calculated by measuring VASP-P levels by mean fluorescence intensity (MFI) by stimulation with prostaglandin; PGE1and PGE1 plus ADP. PRI(%)=[(MFIPGE1)-(MFIPGE1+ADP)/(MFIPGE1)]×100%. ) Pharmacokinetic will be done at 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours. AUC from time 0-2 hours, Cmax at 2 hours, and Tmax at 2 hours for key secondary endpoint. Will collect Cmax and Tmax at all time points to be consistent, i.e. at 0, 30 min, 1 hour, 2 hour, 8 hours, and 24 hours when you draw PD measures at those time points and sample will be shipped.
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- ACS, STEMI, Fibrinolysis, Pharmacodynamics, Pharmacokinetics, Plavix, Brilinta, Ticagrelor, Clopidogrel
- Medical subject headings
- ST Elevation Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
For ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.
ClopidogrelDrug
Also called Plavix
For clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | Ticagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days. Receives: Drug: Ticagrelor |
| Clopidogrel | Active comparator | Clopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days. Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow
Pharmacodynamics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours
Measured: Change from baseline at 2 hours
Secondary outcomes (1)
Pharmacokinetic (AUC, Cmax, Tmax)
Pharmacokinetics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours
Measured: Change from baseline at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study start2 Jan 2014 (estimated)
- Primary completionMay 2015 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: unable to get study up and enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center of South Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh K. Sharma, Medical Center of South Arkansas
- Investigators
- Rakesh K Sharma, MD, FACC, FSCAI, FSCCT, Principal investigator, Medical Center of South Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048085
- Sponsor's protocol ID
- ISSBRIL0224
- Acronym
- TACAT
- Status last verified
- Apr 2018
- First submitted
- 27 Jan 2014
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Pilot Study to Assess the Pharmacodynamics Using Vefiynow and VASP Assay; and Pharmacokinetics of Ticagrelor vs Clopidogrel in Patients Undergoing PCI With History of Fibrinolysis in 24-48 Hours
- ClinicalTrials.gov ID
- NCT02048085
- Acronym / sponsor ID
- TACAT / ISSBRIL0224
- Keywords
- ACS, STEMI, Fibrinolysis, Pharmacodynamics, Pharmacokinetics, Plavix, Brilinta, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to get study up and enrolling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical Center of South ArkansasUniversity, hospital or other
- Study start
- 2 Jan 2014 (estimated)
- Primary completion
- May 2015 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 29 Jan 2014 (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.
This study involves doing platelet function testing in patients who have undergone fibrinolysis. Fibrinolysis (Use of clot busting medicine in heart attack) is the standard of care to restore blood flow in blocked arteries as soon as possible after the "Heart attack" in rural health center where access to cardiac catheterization is one hour away. Fibrinolysis is done by the emergency room physician in a timely fashion to minimize the damage of the myocardium. Additionally anti-platelet regimen as adjuvant for patient undergoing fibrinolysis has been well studied in many trials. In this study investigators will use clopidogrel or ticagrelor in randomized fashion to evaluate anti- platelet effect by measuring efficacy in vivo (pharmacodynamics) and blood levels of both drugs (Pharmacokinetics).
Detailed description
This is an open label randomized pharmacodynamics study to compare platelet function reactivity of ticagrelor and clopidogrel after PCI in sub-set of patients who have undergone fibrinolysis at least 24 hour prior to PCI..A total of 70 patients will be enrolled. Prior to enrollment, patients have already undergone fibrinolysis (selected by the treating physician), aspirin (recommended dose 324 mg) on the first day and 81 mg daily thereafter, and Lovenox or heparin as per protocol of referring ER. Patients will undergo coronary angiography as standard of care and coronary stenting if indicated. Prior to angiography patient will be enrolled in this open label randomized protocol to receive clopidogrel or ticagrelor. Patients will be randomly assigned in a 1:1 ratio by open label study to receive either clopidogrel (Plavix, Sanofi-Aventis and Bristol-Myers Squibb; a 300-mg loading dose followed by 75 mg once daily) or ticagrelor (Brilinta, AstraZeneca; 180 mg loading and 90 mg twice daily) by a computerized system of randomization. Patients will receive clopidogrel or ticagrelor daily from enrollment to discharge. For patients who did not undergo PCI after enrollment, study drugs will be administered up to and including day 8th or hospital discharge, whichever comes first. Patients will be treated as per standard of care, and pharmacodynamics and pharmacokinetic study will be carried as per protocol. VerifyNow and VASP assay will be used to measure platelet reactivity for pharmacodynamic evaluation of ticagrelor vs Clopidogrel at specific time points: baseline (time 0), 30 mins, 1 hour, 2 hours, 8 hours and at 24 hours from first oral anti-platelet dose.. Blood will be collected from the sheath or ante-cubital vein into Vacutainer tubes for platelet function assay as below by VerifyNow and VASP. VerifyNow P2Y12 Assay: VerifyNow is a turbidimetric based system that measures platelet aggregation in the whole blood.8 This instrument measures an optical signal reported as P2Y12 Reaction Units (PRU). Vasodilator-Stimulated Phosphoprotein Phosphrylation (VASP) Assay: The measure of Vasodilator-Stimulated Phosphoprotein Phosphrylation (Biocytex Inc. Marseille, France), a method to quantify P2Y12 receptor reactivity, which reflects the extent of blockade of P2Y12 receptor blockade.9 Platelet reactivity index (PRI) is calculated by measuring VASP-P levels by mean fluorescence intensity (MFI) by stimulation with prostaglandin; PGE1and PGE1 plus ADP. PRI(%)=[(MFIPGE1)-(MFIPGE1+ADP)/(MFIPGE1)]×100%. ) Pharmacokinetic will be done at 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours. AUC from time 0-2 hours, Cmax at 2 hours, and Tmax at 2 hours for key secondary endpoint. Will collect Cmax and Tmax at all time points to be consistent, i.e. at 0, 30 min, 1 hour, 2 hour, 8 hours, and 24 hours when you draw PD measures at those time points and sample will be shipped.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor Arm will be dosed with a loading dose of 180 mg followed by maintenance dose of 90 mg BID until discharge or up to 8 days. |
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel arm will be dose with a loading dose of 300 mg followed by maintenance dose of 75 mg everyday until discharge or up to 8 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women 18 to 75 years of age
- Ischemic discomfort lasting more than 20 mins at rest within 12 hours before randomization
- ST-segment elevation of at least 0.1 mV in at least two contiguous limb leads, ST-segment elevation of at least 0.2 mV in at least two contiguous precordial leads, or left bundle-branch block that was not known to be old
- Received fibrinolytic agent, an anticoagulant (if a fibrin-specific lytic agent was prescribed) and aspirin within 24-48 hours
Key exclusion criteria (12 listed)
- Hypersensitivity to ticagrelor or clopidogrel
- Active Pathological Bleeding or history of intracranial bleeding
- Concomitant use of oral anticoagulant
- Concomitant use of 40 mg of Simvastatin or lovastatin
- Concomitant strong CYP3A inhibitors such as ketoconazole, clarithromycin, nefazadone, ritonavir, atazanavir
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: BrilintaFor ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid. | Drug | Ticagrelor |
| ClopidogrelAlso: PlavixFor clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD | Drug | Clopidogrel |
Primary outcome
Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow
Time frame: Change from baseline at 2 hours
Pharmacodynamics at baseline, 30 min, 60 min, 120 min, 4 hours, 8 hours and at 24 hours
1 secondary outcome
Pharmacokinetic (AUC, Cmax, Tmax)
Time frame: Change from baseline at 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
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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.
Rakesh K Sharma, MD, FACC, FSCAI, FSCCT principal investigator
Medical Center of South Arkansas
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 and Clopidogrel in people with Acute ST Segment Elevation Myocardial Infarction and Acute Coronary Syndrome, run by Medical Center of South Arkansas at 1 site in United States.
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 4 Apr 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacodynamics (PRU and IPA) of ticagrelor vs Clopidogrel using VASP and VerifyNow (time frame: Change from baseline at 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2018.