Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Prasugrel; Clopidogrel
Intervention description: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.; Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; bivalirudin

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.
    

Eligibility 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.