A Clinical Trial to Demonstrate the Efficacy of Cangrelor

Myocardial Infarction (MI) Clinical Trial

— PCI  

Official title:

A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00305162
• Other study ID #: TMC-CAN-05-02
• Status: Terminated
• Phase: Phase 3
• First received: March 17, 2006
• Last updated: April 22, 2014
• Start date: April 2006
• Est. completion date: June 2010

Study information

• Verified date: April 2014
• Source: The Medicines Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8882
• Est. completion date: June 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes (ACS)
• Infarction
• Myocardial Infarction
• Myocardial Infarction (MI)

Intervention

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).
• 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.
• 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)
• Placebo capsules - end of infusion
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing
• Placebo capsules - as soon as possible after randomization
Placebo capsules given as soon as possible after randomization to mimic 600mg clopidogrel dosing

Locations

Country	Name	City	State
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR)	(composite incidence)	randomization through 48 hours after randomization	No
Secondary	Incidence of All-cause Mortality and MI	(composite incidence)	randomization through 48 hours after randomization	No
Secondary	Individual Incidence of All-cause Mortality		randomization through 48 hours after randomization	No
Secondary	Individual Incidence of IDR		randomization through 48 hours after randomization	No
Secondary	Incidence of Stroke	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.	randomization through 48 hours after randomization	No
Secondary	Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI	(a patient could have multiple procedural events)	during index PCI	No
Secondary	Incidence of All-cause Mortality, MI or IDR	(composite incidence)	randomization through 30 days after randomization	No
Secondary	Incidence of All-cause Mortality or MI	(composite incidence)	randomization through 30 days after randomization	No
Secondary	Incidence of All-cause Mortality		randomization through 30 days after randomization	No
Secondary	Incidence of MI		randomization through 30 days after randomization	No
Secondary	Incidence of IDR		randomization through 30 days after randomization	No
Secondary	Incidence of Stroke		randomization through 30 days after randomization	No
Secondary	Incidence of All Cause Mortality	(excluding STEMI)	randomization through 1 year after randomization	No
Secondary	Incidence of GUSTO Severe / Life-threatening Bleeding	Major bleeding (non-CABG-related) - Safety population	randomization through 48 hours after randomization	Yes
Secondary	Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding	Major bleeding (non-CABG-related) - Safety population	randomization through 48 hours after randomization	Yes
Secondary	Incidence of ACUITY Major Bleeding	Major bleeding (non-CABG-related) - Safety population	randomization through 48 hours after randomization	Yes
Secondary	Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm)	excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm	randomization through 48 hours after randomization	Yes