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

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ClinicalTrials.gov Identifier: NCT00385138
Recruitment Status : Terminated (Insufficient evidence of the clinical effectiveness of cangrelor)
First Posted : October 6, 2006
Results First Posted : April 21, 2014
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Atherosclerosis Acute Coronary Syndrome (ACS) Drug: Cangrelor Drug: clopidogrel Drug: Placebo bolus & placebo infusion Drug: Placebo capsules - end of PCI Drug: Placebo capsules - end of infusion Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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).
Study Start Date : September 2006
Primary Completion Date : May 2009
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cangrelor
cangrelor bolus (30 mcg/kg) & 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 (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
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)
Drug: clopidogrel
clopidogrel capsules (600 mg) at end of PCI
Other Name: Plavix
Drug: Placebo capsules - end of PCI
Placebo capsules given at the end of PCI to mimic 600mg clopidogrel dosing
Active Comparator: Clopidogrel
placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
Drug: clopidogrel
clopidogrel capsules (600 mg) at end of PCI
Other Name: Plavix
Drug: 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)
Drug: Placebo capsules - end of infusion
Placebo capsules given at the end of infusion to mimic 600mg clopidogrel dosing


Outcome Measures

Primary Outcome Measures :
  1. Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) [ Time Frame: randomization through 48 hours post randomization ]
    mITT population; (composite incidence)


Secondary Outcome Measures :
  1. Incidence of All-cause Mortality or MI [ Time Frame: randomization through 48 hours post randomization ]
    mITT population

  2. Incidence of All-cause Mortality [ Time Frame: randomization through 48 hours post randomization ]
    mITT population

  3. Incidence of MI [ Time Frame: randomization through 48 hours post randomization ]
    mITT population

  4. Incidence of IDR [ Time Frame: randomization through 48 hours post randomization ]
    mITT population

  5. Incidence of Stent Thrombosis [ Time Frame: randomization through 48 hours post randomization ]
    mITT population

  6. Incidence of Stroke [ Time Frame: randomization through 48 hours post randomization ]
    mITT

  7. Incidence of All-cause Mortality [ Time Frame: randomization through 1 year post randomization ]
    mITT population

  8. 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] [ Time Frame: During index PCI ]
    mITT population A patient could have multiple procedural events.

  9. Incidence of GUSTO Severe / Life-threatening [ Time Frame: randomization through 48 hours post randomization ]
    Major bleeding (non-CABG-related) - Safety population

  10. Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major [ Time Frame: randomization through 48 hours post randomization ]
    Major bleeding (non-CABG-related) - Safety population

  11. Incidence of ACUITY Major Bleeding [ Time Frame: randomization through 48 hours post randomization ]
    Major bleeding (non-CABG-related) - Safety population

  12. Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm [ Time Frame: randomization through 48 hours post randomization ]
    Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm.

  13. Incidence of All-cause Mortality, MI, or IDR [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  14. Incidence of All-cause Mortality or MI [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  15. Incidence of All-cause Mortality [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  16. Incidence of MI [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  17. Incidence of IDR [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  18. Incidence of Stent Thrombosis [ Time Frame: randomization through 30 days post randomization ]
    mITT population

  19. Incidence of Stroke [ Time Frame: randomization through 30 days post randomization ]
    mITT population


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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]
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385138


Locations
United States, North Dakota
Innovis Health
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Simona Skerjanec, PharmD The Medicines Company
Principal Investigator: Deepak L. Bhatt, MD The Cleveland Clinic
Principal Investigator: Robert A. Harrington, MD Duke University
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00385138     History of Changes
Other Study ID Numbers: TMC-CAN-05-03
First Posted: October 6, 2006    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: May 5, 2014
Last Verified: April 2014

Keywords provided by The Medicines Company:
Percutaneous Coronary Intervention (PCI)
ACS

Additional relevant MeSH terms:
Atherosclerosis
Acute Coronary Syndrome
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Clopidogrel
Cangrelor
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors