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Completed

NCT Number: NCT01156571

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients may be included in the study if they meet all of the following criteria:

  • Male or non-pregnant female at least 18 years of age
  • Patients undergoing percutaneous coronary intervention (PCI):
  • Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
  • Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
  • ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
  • Provide written informed consent

Exclusion criteria

Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

  • Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
  • Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
  • Abciximab usage within 7 days preceding randomization
  • Receipt of fibrinolytic therapy in the 12 hours preceding randomization
  • 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 bypass surgery); currently receiving warfarin; active bleeding

Treatment and study plan

cangrelor P2Y12 (platelet) inhibitor

Drug

Clopidogrel - 300 or 600 mg (study arm)

Drug

Over encapsulated tablets.

Clopidogrel 600 mg post cangrelor

Drug

over-encapsulated clopidogrel (600 mg)

Primary outcomes

  1. The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)

    Time frame: 48 hours after randomization

    Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)

Secondary outcomes

  1. Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)

    Time frame: 48 hours after randomization

    CEC-adjudicated results (mITT population)

  2. Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild

    Time frame: 48 hours after randomization

    GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial

Sponsors and collaborators

Lead sponsor

The Medicines Company

Industry

Registry information

Official study title

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)

Acronym: CHAMPION

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 5, 2010
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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