A Clinical Trial to Demonstrate the Efficacy of Cangrelor

Condition(s) targeted: Unstable Angina; Myocardial Infarction; Acute Coronary Syndromes

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

Phase: Phase 3

Status: Recruiting

Sponsored by: The Medicines Company

Official(s) and/or principal investigator(s):
Deepak L. Bhatt, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Robert A. Harrington, MD, Principal Investigator, Affiliation: Duke University Medical Center and Duke Clinical Research Institute
Simona Skerjanec, PharmD, Study Director, Affiliation: The Medicines Company

Overall contact:
Meredith Todd, Phone: 973-647-6088, Email: Meredith.Todd@themedco.com

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)

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

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

Primary outcome: All-cause mortality, MI, and IDR

Secondary outcome: Death, IDR

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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:

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 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.

Meredith Todd, Phone: 973-647-6088, Email: Meredith.Todd@themedco.com

Pennsylvania Hospital, Philadelphia, Pennsylvania 19107-6192, United States; Recruiting
Charles V. Pollack, Jr., M.D., Phone: 215-829-3264

Starting date: April 2006
Ending date: December 2009
Last updated: August 28, 2008