Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.

Atherosclerosis Clinical Trial

— Platform  

Official title:

A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention (PCI).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385138
• Other study ID #: TMC-CAN-05-03
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Atherosclerosis

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