Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.

Last updated: April 18, 2014
Sponsor: The Medicines Company
Overall Status: Terminated

Phase

3

Condition

Atherosclerosis

Myocardial Ischemia

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT00385138
TMC-CAN-05-03
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR).

Eligibility Criteria

Inclusion

Inclusion Criteria: Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronaryintervention (PCI) with or without stent implantation and diagnosis of Acute CoronarySyndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogramchanges + age > 65 or diabetes.

Exclusion

Exclusion Criteria:

  1. Not a candidate for PCI

  2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization

  3. Increased bleeding risk: ischemic stroke within the last year or any previoushemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, orintracranial aneurysm; recent (<1 month) trauma or major surgery [including coronaryartery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding

  4. Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening;past or present bleeding disorder (including congenital bleeding disorders such as vonWillebrand's disease or hemophilia, acquired bleeding disorders, and unexplainedclinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening

  5. Severe hypertension not adequately controlled by antihypertensive therapy at the timeof randomization

  6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization

  7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days precedingrandomization

  8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicableto unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients]

Study Design

Total Participants: 5364
Study Start date:
September 01, 2006
Estimated Completion Date:
June 30, 2010

Connect with a study center

  • Innovis Health

    Fargo, North Dakota 58104
    United States

    Site Not Available

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