A Clinical Trial to Demonstrate the Efficacy of Cangrelor (PCI)

This study has been terminated.
(Insufficient evidence of the clinical effectiveness of cangrelor)
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00305162
First received: March 17, 2006
Last updated: January 13, 2012
Last verified: January 2012

March 17, 2006
January 13, 2012
April 2006
May 2009   (final data collection date for primary outcome measure)
All-cause mortality, MI, and IDR [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
All-cause mortality, MI, and IDR in the 48 hours after randomization.
Complete list of historical versions of study NCT00305162 on ClinicalTrials.gov Archive Site
Death, IDR [ Time Frame: 30 days ] [ Designated as safety issue: No ]
All-cause mortality and MI at 48 hours
Not Provided
Not Provided
 
A Clinical Trial to Demonstrate the Efficacy of Cangrelor
A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention.

The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.

Two (2) separate sub-studies will be conducted at selected study sites:

  • TMC-CAN-05-02-S1 "The effect of cangrelor on the pharmacodynamics of clopidogrel" to determine whether the administration of a cangrelor infusion prior to administration of a 600 mg loading dose of clopidogrel has any effect on the extent of platelet inhibition by clopidogrel
  • TMC-CAN-05-02-S2 "A cangrelor population pharmacokinetics modeling study" to develop a population pharmacokinetic (PK) model for cangrelor from data obtained from ongoing Phase III studies of patients with coronary atherosclerosis requiring percutaneous coronary intervention (PCI)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Unstable Angina
  • Myocardial Infarction
  • Acute Coronary Syndromes
  • Drug: cangrelor (P2Y12 inhibitor)
    Bolus (30 ug/kg) & infusion (4 ug/kg/min) administered within 30 minutes of the start of PCI - infusion to continue minimum of 2 hours and no longer than 4 hours.
  • Drug: clopidogrel (P2Y12 inhibitor)
    600 mg active clopidogrel given 30 minutes prior to the start of PCI.
    Other Name: Plavix
  • Experimental: 1
    placebo capsules (to match) + cangrelor bolus -(30 ug/kg) & infusion (4ug/kg/min)
    Intervention: Drug: cangrelor (P2Y12 inhibitor)
  • Active Comparator: 2
    clopidrogrel capsules (600 mg) + placebo bolus & infusion (to match)
    Intervention: Drug: clopidogrel (P2Y12 inhibitor)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8882
June 2010
May 2009   (final data collection date for primary outcome measure)

INCLUSION CRITERIA

To be included in this study, subjects must meet the following criteria:

  • Angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation and diagnosis of Acute Coronary Syndrome by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes or ST-elevation MI.

EXCLUSION CRITERIA

Subjects will be excluded from the study if they present with any of the following:

  1. Not a candidate for PCI
  2. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including by-pass surgery); currently receiving warfarin, active bleeding
  3. Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel
  4. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
  5. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
  6. Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization
  7. Inability to swallow study capsules
  8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours (applicable to UA and NSTEMI patients)

Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00305162
TMC-CAN-05-02
Yes
The Medicines Company
The Medicines Company
Not Provided
Principal Investigator: Deepak L. Bhatt, MD The Cleveland Clinic
Principal Investigator: Robert A. Harrington, MD Duke University Medical Center and Duke Clinical Research Institute
Study Director: Simona Skerjanec, PharmD The Medicines Company
The Medicines Company
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP