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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00385138
Other study ID # TMC-CAN-05-03
Secondary ID
Status Terminated
Phase Phase 3
First received October 4, 2006
Last updated April 18, 2014
Start date September 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 (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).


Recruitment information / eligibility

Status Terminated
Enrollment 5364
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:

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

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


Intervention

Drug:
Cangrelor
cangrelor bolus (30 mcg/kg) & cangrelor 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)
clopidogrel
clopidogrel capsules (600 mg) at end of PCI
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 PCI
Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
Placebo capsules - end of infusion
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing

Locations

Country Name City State
United States Innovis Health Fargo North Dakota

Sponsors (1)

Lead Sponsor Collaborator
The Medicines Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; CHAMPION PLA — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) mITT population; (composite incidence) randomization through 48 hours post randomization No
Secondary Incidence of All-cause Mortality or MI mITT population randomization through 48 hours post randomization No
Secondary Incidence of All-cause Mortality mITT population randomization through 48 hours post randomization No
Secondary Incidence of MI mITT population randomization through 48 hours post randomization No
Secondary Incidence of IDR mITT population randomization through 48 hours post randomization No
Secondary Incidence of Stent Thrombosis mITT population randomization through 48 hours post randomization No
Secondary Incidence of Stroke mITT randomization through 48 hours post randomization No
Secondary Incidence of All-cause Mortality mITT population randomization through 1 year post randomization No
Secondary 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] mITT population A patient could have multiple procedural events. During index PCI No
Secondary Incidence of GUSTO Severe / Life-threatening Major bleeding (non-CABG-related) - Safety population randomization through 48 hours post randomization Yes
Secondary Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Major bleeding (non-CABG-related) - Safety population randomization through 48 hours post randomization Yes
Secondary Incidence of ACUITY Major Bleeding Major bleeding (non-CABG-related) - Safety population randomization through 48 hours post randomization Yes
Secondary Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm. randomization through 48 hours post randomization Yes
Secondary Incidence of All-cause Mortality, MI, or IDR mITT population randomization through 30 days post randomization No
Secondary Incidence of All-cause Mortality or MI mITT population randomization through 30 days post randomization No
Secondary Incidence of All-cause Mortality mITT population randomization through 30 days post randomization No
Secondary Incidence of MI mITT population randomization through 30 days post randomization No
Secondary Incidence of IDR mITT population randomization through 30 days post randomization No
Secondary Incidence of Stent Thrombosis mITT population randomization through 30 days post randomization No
Secondary Incidence of Stroke mITT population randomization through 30 days post randomization No
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