A Clinical Trial to Demonstrate the Efficacy of Cangrelor

Phase 3

Terminated

• Conditions: Myocardial Infarction (MI); Acute Coronary Syndromes (ACS)
• Interventions: Drug: Cangrelor (P2Y12 inhibitor); Drug: Placebo bolus & placebo infusion; Drug: clopidogrel (oral P2Y12 inhibitor); Drug: Placebo capsules - as soon as possible after randomization; Drug: Placebo capsules - end of infusion

• Registration Number: NCT00305162
• Lead Sponsor: The Medicines Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-17
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-21
• Study Start: 2006-04
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Results First Submitted: 2013-04-22
• Results First Submitted QC: 2014-03-25
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-22
• Results First Posted: 2014-04-23
• Last Update Posted: 2014-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8882

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cangrelor	Placebo capsules - as soon as possible after randomization	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
Clopidogrel	Placebo bolus & placebo infusion	clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion
Clopidogrel	Placebo capsules - end of infusion	clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion
Cangrelor	Cangrelor (P2Y12 inhibitor)	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
Cangrelor	clopidogrel (oral P2Y12 inhibitor)	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
Clopidogrel	clopidogrel (oral P2Y12 inhibitor)	clopidogrel capsules (600 mg) + placebo bolus \& infusion (to match) + placebo capsules (to match) post infusion

Primary Outcome Measures

Name	Time	Method
Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)	randomization through 48 hours after randomization	(composite incidence)

Secondary Outcome Measures

Name	Time	Method
Incidence of IDR	randomization through 30 days after randomization
Incidence of All-cause Mortality and MI	randomization through 48 hours after randomization	(composite incidence)
Individual Incidence of All-cause Mortality	randomization through 48 hours after randomization
Individual Incidence of IDR	randomization through 48 hours after randomization
Incidence of Stroke	randomization through 30 days after randomization
Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI	during index PCI	(a patient could have multiple procedural events)
Incidence of All-cause Mortality, MI or IDR	randomization through 30 days after randomization	(composite incidence)
Incidence of All-cause Mortality or MI	randomization through 30 days after randomization	(composite incidence)
Incidence of All-cause Mortality	randomization through 30 days after randomization
Incidence of MI	randomization through 30 days after randomization
Incidence of GUSTO Severe / Life-threatening Bleeding	randomization through 48 hours after randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of All Cause Mortality	randomization through 1 year after randomization	(excluding STEMI)
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding	randomization through 48 hours after randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of ACUITY Major Bleeding	randomization through 48 hours after randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)	randomization through 48 hours after randomization	excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm

Trial Locations

Locations (1)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States