A Clinical Trial to Demonstrate the Efficacy of Cangrelor - Full Text View

Sponsor:	The Medicines Company
Information provided by:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00305162

Purpose

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)

Condition	Intervention	Phase
Unstable Angina Myocardial Infarction Acute Coronary Syndromes	Drug: cangrelor (P2Y12 inhibitor) Drug: clopidogrel (P2Y12 inhibitor)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention.

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Clopidogrel Clopidogrel Bisulfate Cangrelor

U.S. FDA Resources

Further study details as provided by The Medicines Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	9000
Study Start Date:	April 2006
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental placebo capsules (to match) + cangrelor bolus -(30 ug/kg) & infusion (4ug/kg/min)	Drug: cangrelor (P2Y12 inhibitor) Bolus (30 ug/kg) & infusion (4 ug/kg/min) administered within 30 minutes of the start of PCI - infusion to continue minimum of 2 hours and no longer than 4 hours.
2: Active Comparator clopidrogrel capsules (600 mg) + placebo bolus & infusion (to match)	Drug: clopidogrel (P2Y12 inhibitor) 600 mg active clopidogrel given 30 minutes prior to the start of PCI.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305162

Locations

United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107-6192

Sponsors and Collaborators

The Medicines Company

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

More Information

No publications provided by The Medicines Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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 with cangrelor in patients undergoing PCI. N Engl J Med. 2009 Dec 10;361(24):2318-29.

Responsible Party:	The Medicines Company ( Simona Skerjanec, PharmD )
Study ID Numbers:	TMC-CAN-05-02
Study First Received:	March 17, 2006
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00305162 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Medicines Company:

Acute Coronary Syndrome
PCI
NStemi

Additional relevant MeSH terms:

Disease
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Pharmacologic Actions
Chest Pain
Signs and Symptoms

Necrosis
Pathologic Processes
Therapeutic Uses
Clopidogrel
Syndrome
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Infarction
Angina, Unstable
Myocardial Infarction

ClinicalTrials.gov processed this record on February 08, 2010