A Clinical Trial to Demonstrate the Efficacy of Cangrelor - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 17, 2006

Last Updated Date

February 9, 2009

Start Date ^†

April 2006

Current Primary Outcome Measures ^†

All-cause mortality, MI, and IDR [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00305162 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Death, IDR [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Clinical Trial to Demonstrate the Efficacy of Cangrelor

Official Title ^†

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

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.

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)

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^†

Unstable Angina
Myocardial Infarction
Acute Coronary Syndromes

Intervention ^†

Drug: cangrelor (P2Y12 inhibitor)
Drug: clopidogrel (P2Y12 inhibitor)

Study Arms / Comparison Groups

Experimental: placebo capsules (to match) + cangrelor bolus -(30 ug/kg) & infusion (4ug/kg/min)
Active Comparator: clopidrogrel capsules (600 mg) + placebo bolus & infusion (to match)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

9000

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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:

Not a candidate for PCI
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
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
Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization
Inability to swallow study capsules
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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Meredith Todd

973-290-6088

Meredith.Todd@themedco.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00305162

Responsible Party

Simona Skerjanec, PharmD, The Medicines Company

Secondary IDs ^††

Study Sponsor ^†

The Medicines Company

Collaborators ^††

Investigators ^†

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

Information Provided By

The Medicines Company

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.