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: April 22, 2014
Last verified: April 2014

March 17, 2006
April 22, 2014
April 2006
May 2009   (final data collection date for primary outcome measure)
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: No ]
(composite incidence)
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
  • Incidence of All-cause Mortality and MI [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: No ]
    (composite incidence)
  • Individual Incidence of All-cause Mortality [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: No ]
  • Individual Incidence of IDR [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: No ]
  • Incidence of Stroke [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: No ]

    Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as:

    • primary hemorrhagic - stroke with focal collections of intracranial blood
    • ischemic cerebral infarction - stroke without focal collections of intracranial blood
    • infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding
    • uncertain - no imaging or autopsy data are available.
  • Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI [ Time Frame: during index PCI ] [ Designated as safety issue: No ]
    (a patient could have multiple procedural events)
  • Incidence of All-cause Mortality, MI or IDR [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
    (composite incidence)
  • Incidence of All-cause Mortality or MI [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
    (composite incidence)
  • Incidence of All-cause Mortality [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
  • Incidence of MI [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
  • Incidence of IDR [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
  • Incidence of Stroke [ Time Frame: randomization through 30 days after randomization ] [ Designated as safety issue: No ]
  • Incidence of All Cause Mortality [ Time Frame: randomization through 1 year after randomization ] [ Designated as safety issue: No ]
    (excluding STEMI)
  • Incidence of GUSTO Severe / Life-threatening Bleeding [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: Yes ]
    Major bleeding (non-CABG-related) - Safety population
  • Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: Yes ]
    Major bleeding (non-CABG-related) - Safety population
  • Incidence of ACUITY Major Bleeding [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: Yes ]
    Major bleeding (non-CABG-related) - Safety population
  • Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm) [ Time Frame: randomization through 48 hours after randomization ] [ Designated as safety issue: Yes ]
    excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm
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 (PCI).

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.

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
  • Myocardial Infarction (MI)
  • Acute Coronary Syndromes (ACS)
  • Drug: Cangrelor (P2Y12 inhibitor)
    IV bolus (30 mcg/kg) & infusion (4 mcg/kg/min) initiated prior to PCI, as soon as possible following randomization (after need for PCI is confirmed) but not more than 30 minutes prior to placement of arterial access. Infusion is to continue for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion).
  • Drug: clopidogrel (oral P2Y12 inhibitor)
    600 mg active clopidogrel administered as soon as possible following randomization (after need for PCI confirmed), but not more than 30 minutes prior to the placement of the arterial access.
    Other Name: Plavix
  • Drug: Placebo bolus & placebo infusion
    placebo bolus (30 mcg/kg) & placebo infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion)
  • Drug: Placebo capsules - end of infusion
    Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
  • Drug: Placebo capsules - as soon as possible after randomization
    Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing
  • Experimental: Cangrelor
    placebo capsules (to match) + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
    Interventions:
    • Drug: Cangrelor (P2Y12 inhibitor)
    • Drug: clopidogrel (oral P2Y12 inhibitor)
    • Drug: Placebo capsules - as soon as possible after randomization
  • Active Comparator: Clopidogrel
    clopidogrel capsules (600 mg) + placebo bolus & infusion (to match) + placebo capsules (to match) post infusion
    Interventions:
    • Drug: clopidogrel (oral P2Y12 inhibitor)
    • Drug: Placebo bolus & placebo infusion
    • Drug: Placebo capsules - end of infusion

*   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 percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) 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 unstable angina (UA) and non-ST-elevation myocardial infarction (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
April 2014

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