Phase 4 N=24 Randomized Treatment

Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT01789814 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF. — 84; 38; 94; 53 % inhibitn of platelet aggregation — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Prasugrel (Drug); Clopidogrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tufts Medical Center
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.	84; 38; 94; 53; 98; 85	0.001 sig

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

Signed informed consent before initiation of any study related procedures
Male or non-pregnant female aged 18 to ≤ 75 years
Referred for PCI or structural cardiac intervention and planned to receive bivalirudin treatment
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

Currently receiving glycoprotein IIb/IIIa inhibitors.
Have received prasugrel or clopidogrel within 2 weeks
Serum creatinine level >2.0
Hypersensitivity to bivalirudin, prasugrel, clopidogrel or aspirin
Currently on heparin administration or administered ≤ 4.5 h prior to intervention
Thrombocytopenia ( 180 mm Hg and/or diastolic blood pressure >110 mm Hg
Body weight < 60 kg
Cardiogenic shock
Acute pericarditis
Active internal bleeding
History of bleeding diathesis within previous thirty days
Any history of intracranial hemorrhage, Transient ischemic attack (TIA ) or stroke
Arteriovenous malformations or aneurysms
Major surgical procedures or severe physical trauma within last thirty days.
Symptoms or findings suggestive of aortic dissection
Pregnancy
Participation in other clinical research studies involving the evaluation of investigational drugs or devices within 30 days of enrollment
Incompetent subjects or subjects otherwise unable to provide informed consent
Subjects in whom the treating physician believes that one agent (prasugrel or clopidogrel) is preferable over the other will be excluded from study participation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01789814). 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.