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Effect of Prasugrel Versus Clopidogrel on Platelet Function After Bivalirudin Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01789814
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
Tufts Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Prasugrel Drug: Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF. [ Time Frame: Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion ]

    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.

    The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01789814

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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
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Principal Investigator: Carey Kimmelstiel, MD Tufts Medical Center

Additional Information:
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Responsible Party: Tufts Medical Center Identifier: NCT01789814     History of Changes
Other Study ID Numbers: PraCloBiv2013CK
TMCcardintervCK2013 ( Other Identifier: Tufts Medical Center )
First Posted: February 12, 2013    Key Record Dates
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by Tufts Medical Center:
Percutaneous Coronary Intervention
Platelet Aggregation Inhibitors
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents