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OpenTrials
Completed

NCT Number: NCT00767507

Maintenance of Platelet Inhibition With Cangrelor

The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.

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Key information

Conditions

Acute Coronary Syndrome (ACS) Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Scripps Clinic / Scripps Green Hospital

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • 18 Years of Age
  • Non emergent coronary bypass graft surgery
  • Received a thienopyridine within 48 hours prior to enrollment

Exclusion criteria

  • Confirmed or suspected pregnancy
  • Cerebrovascular accident within one yar
  • Intracranial neoplasm
  • History of bleeding diathesis
  • Thrombocytopenia

Treatment and study plan

cangrelor

Drug

Placebo

Other

Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Primary outcomes

  1. Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.

    Time frame: During study drug infusion up to 1-6 hours prior to surgery

    Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).

  2. Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.

    Time frame: During study drug infusion up to 1-6 hours prior to surgery

    This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.

    Patients had multiple samples and all "on-infusion" samples had to be <240 PRU to meet the endpoint.

Secondary outcomes

  1. Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU

    Time frame: baseline until just prior to surgery (post infusion)

    This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:

    • Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)
    • Last sample during infusion
    • Following discontinuation of study drug infusion

  2. Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding

    Time frame: Randomization through Hospital discharge

    Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units

  3. Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild

    Time frame: Randomization until start of CABG surgery

  4. Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner

    Time frame: Through 7 days or hospital discharge, whichever was sooner

Sponsors and collaborators

Lead sponsor

The Medicines Company

Industry

Registry information

Official study title

BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

Acronym: Bridge

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2008
Registry last updated
Apr 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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