Phase 4
N=56
Prasugrel/Clopidogrel Maintenance Dose Washout Study
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01014624 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline — 0; 30.8; 3.6; 53.9 cumulative percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prasugrel (Drug); Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline |
0; 30.8; 3.6; 53.9; 37.0; 84.6 | — |
| PRIMARY The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline |
0.0; 30.8; 0.0; 53.9; 37.0; 80.8 | — |
| SECONDARY Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population |
6; 3; 7; 5; 9; 6 | — |
| SECONDARY Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population |
6; 3; 7; 5; 9; 7 | — |
| SECONDARY Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population |
6; 5; 7; 5; 9; 6 | — |
| SECONDARY Day at Which 50%, 75%, and 90% of Participants Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population |
6; 5; 7; 6; 9; 7 | — |
| SECONDARY Percentage of Inhibition of Platelet Aggregation on Washout Day 1 |
72.3; 35.4 | — |
| SECONDARY Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose |
6.2; 3.7 | — |
Summary
The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The primary analysis is descriptive and is intended to provide information relating to the return of baseline platelet function following discontinuation of maintenance therapy with either prasugrel or clopidogrel.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects >/= 18 years and /= 60 kg
- On aspirin therapy (81 mg to 325 mg daily) at the time of screening and able to maintain a consistent aspirin dosing regimen from the baseline visit through the final study visit
- Subjects who do not have contraindications for a thienopyridine (ie, prasugrel, clopidogrel or ticlopidine), and have a history of stable atherosclerosis represented by Coronary Artery disease, defined as any of the following:
- chronic stable angina
- Prior history of acute coronary syndrome (>/= 30 days before screening) including unstable angina or acute myocardial infarction (ST elevation Myocardial Infarction [STEMI] or non-ST elevation Myocardial Infarction [NSTEMI]), not currently prescribed or currently on thienopyridine therapy;
- Previous coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA), stent, or coronary artery bypass grafting (CABG) coronary artery disease (>/= 50% obstruction) in at least one coronary vessel after angiography
- Female subjects who meet one of the following:
- Women of childbearing potential with a negative serum pregnancy test at screening who are not breast feeding, do not plan to become pregnant during the study, and agree to use an approved method of birth control during the study. Approved methods of birth control are oral, path, injectable or implantable hormonal contraception, intrauterine device, diaphragm plus spermicide, or female condom plus spermicide. Abstinence, partner's use of condoms, and partner's vasectomy are NOT acceptable methods of contraception.
- Women who have been postmenopausal for at least 1 year or have had a hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation at least 6 months prior to signing the informed consent form.
- Subjects with a competent mental condition to provide written informed consent before entering the study.
Exclusion Criteria
- Any other formal indication for the use of a thienopyridine.
- Subjects with a history of refractory ventricular arrhythmias.
- Subjects with a history of an implantable defibrillator device.
- Subjects with a history or evidence of congestive heart failure (New York Heart Association [NYHA] Class III or above) within 6 months prior to screening.
- Subjects with significant hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at either the time of screening or baseline assessment.
- Bleeding Risk Exclusion Criteria:
- Any known contraindication to treatment with an anticoagulant or antiplatelet agent
- Prior history or clinical suspicion of cerebral vascular malformations, intracranial tumor, transient ischemic attack (TIA), or stroke, or recent history (within 3 months) of head trauma
- Prior history or presence of significant bleeding disorders (eg, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding)
- History (within the last 5 years) or presence of gastric ulcers. Previous history of duodenal ulcer is acceptable but must have been successfully surgically or medically treated with no further evidence of disease in the past 6 months (from screening).
- Prior history of abnormal bleeding tendency (ie, prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure)
- Known prior history of thrombocytopenia (platelet count 500,000/mm³) or recent history (within six months) of hemoglobin /= 3 times the upper limit of normal (ULN) laboratory reference range; or bilirubin >/= 2 times the ULN of laboratory reference range at screening
- Subjects who are unreliable and unwilling to make themselves available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
- Subjects who have had an angiogram </= 7 days before randomization
Data sourced from ClinicalTrials.gov (NCT01014624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.