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

Phase 3

Terminated

• Conditions: Atherosclerosis; Acute Coronary Syndrome (ACS)
• Interventions: Drug: Cangrelor; Drug: Placebo bolus & placebo infusion; Drug: clopidogrel; Drug: Placebo capsules - end of PCI; Drug: Placebo capsules - end of infusion

• Registration Number: NCT00385138
• Lead Sponsor: The Medicines Company

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-05
• Study First Posted: 2006-10-06
• Primary Completion: 2009-05
• Study Completion: 2010-06
• Results First Submitted: 2013-04-22
• Results First Submitted QC: 2014-03-24
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-18
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5364

Inclusion 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.

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 previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery 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 von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL) at screening
5. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cangrelor	Placebo capsules - end of PCI	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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
Clopidogrel	Placebo bolus & placebo infusion	placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Clopidogrel	Placebo capsules - end of infusion	placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Cangrelor	clopidogrel	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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
Clopidogrel	clopidogrel	placebo bolus \& infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Cangrelor	Cangrelor	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) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately 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 post randomization	mITT population; (composite incidence)

Secondary Outcome Measures

Name	Time	Method
Incidence of All-cause Mortality	randomization through 30 days post randomization	mITT population
Incidence of MI	randomization through 30 days post randomization	mITT population
Incidence of Stroke	randomization through 30 days post randomization	mITT population
Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis]	During index PCI	mITT population A patient could have multiple procedural events.
Incidence of GUSTO Severe / Life-threatening	randomization through 48 hours post randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major	randomization through 48 hours post randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of ACUITY Major Bleeding	randomization through 48 hours post randomization	Major bleeding (non-CABG-related) - Safety population
Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm	randomization through 48 hours post randomization	Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma \>/= 5 cm.
Incidence of All-cause Mortality or MI	randomization through 30 days post randomization	mITT population
Incidence of IDR	randomization through 30 days post randomization	mITT population
Incidence of Stent Thrombosis	randomization through 30 days post randomization	mITT population
Incidence of All-cause Mortality, MI, or IDR	randomization through 30 days post randomization	mITT population

Trial Locations

Locations (1)

Innovis Health; 🇺🇸 Fargo, North Dakota, United States