Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation

This study is currently recruiting participants.
Verified April 2014 by Tufts Medical Center
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01789814
First received: February 4, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Prasugrel
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Prasugrel as Compared to Clopidogrel on Platelet Function Immediately Following the Termination of Intravenous Bivalirudin in Patients Undergoing Percutaneous Coronary and Structural Cardiac Intervention

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Change from baseline in ADP-mediated platelet aggregation [ Time Frame: Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion ] [ Designated as safety issue: No ]
    To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel.


Secondary Outcome Measures:
  • Inhibition of PAR-1 platelet thrombin receptor [ Time Frame: Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion ] [ Designated as safety issue: No ]
    To document the extent of inhibition of the PAR-1 thrombin receptor following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel
Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention
Drug: Prasugrel
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.
Other Name: Effient
Active Comparator: Clopidogrel
Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention
Drug: Clopidogrel
Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
Other Name: Plavix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789814

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Vilma Castaneda, MD    617-636-7537    VCastaneda@tuftsmedicalcenter.org   
Principal Investigator: Carey Kimmelstiel, MD         
Sub-Investigator: Andrew Weintraub, MD         
Sub-Investigator: Navin Kapur, MD         
Sub-Investigator: Sunu Thomas, MD         
Sub-Investigator: Tarunjit Singh, MD         
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Carey Kimmelstiel, MD Tufts Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01789814     History of Changes
Other Study ID Numbers: PraCloBiv2013CK, TMCcardintervCK2013
Study First Received: February 4, 2013
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
bivalirudin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Ticlopidine
Prasugrel
Bivalirudin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014