Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Early stent thrombosis has been noted with increased frequency in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) who are treated with bivalirudin and clopidogrel. The brief half life of bivalirudin acting in concert with the delayed action of clopidogrel likely exposes patients to thrombosis during a vulnerable period of reduced antiplatelet effect in the immediate post stenting period. Combination therapy with bivalirudin and prasugrel is conceptually attractive as the more rapid onset of action of prasugrel could potentially significantly diminish the vulnerable period, likely reducing the potential for acute stent thrombosis. The trials which have documented the efficacy of prasugrel as compared to clopidogrel have, in general, not reported on patients in whom bivalirudin was utilized. Currently, in the United States, bivalirudin is the most commonly used adjunctive agent used during PCI. Using light transmission aggregometry, this study will examine the inhibition of platelet aggregation in patients randomized to treatment with clopidogrel vs prasugrel during the vulnerable period following the discontinuation of bivalirudin therapy. The investigators anticipate that this study will document significant enhancement of inhibition of platelet aggregation in patients randomized to prasugrel treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tufts Medical Center
• Treatments: Bivalirudin; Clopidogrel; Hirudins; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Ticlopidine

Criteria

Inclusion Criteria:

1. Signed informed consent before initiation of any study related procedures

2. Male or non-pregnant female aged 18 to ≤ 75 years

3. Referred for PCI or structural cardiac intervention and planned to receive bivalirudin treatment

4. Only subjects in whom the treating physician feels that clopidogrel and prasugrel are equivalent on the basis of available clinical literature will be included.

Exclusion Criteria:

1. Currently receiving glycoprotein IIb/IIIa inhibitors.

2. Have received prasugrel or clopidogrel within 2 weeks

3. Serum creatinine level >2.0

4. Hypersensitivity to bivalirudin, prasugrel, clopidogrel or aspirin

5. Currently on heparin administration or administered ≤ 4.5 h prior to intervention

6. Thrombocytopenia (<50,000/µL)

7. Severe systemic hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg

8. Body weight < 60 kg

9. Cardiogenic shock

10. Acute pericarditis

11. Active internal bleeding

12. History of bleeding diathesis within previous thirty days

13. Any history of intracranial hemorrhage, Transient ischemic attack (TIA ) or stroke

14. Arteriovenous malformations or aneurysms

15. Major surgical procedures or severe physical trauma within last thirty days.

16. Symptoms or findings suggestive of aortic dissection

17. Pregnancy

18. Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment

19. Incompetent subjects or subjects otherwise unable to provide informed consent

20. Subjects in whom the treating physician believes that one agent (prasugrel or clopidogrel) is preferable over the other will be excluded from study participation.