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Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass

This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 18, 2006
Last updated: November 17, 2016
Last verified: November 2016
The purpose of this trial is to identify a dose or doses of INS50589 intravenous infusion that are well-tolerated and which reduce postoperative bleeding and blood product transfusion.

Condition Intervention Phase
Coronary Disease
Drug: INS50589 Intravenous Infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel Group Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Graft Surgery Involving Cardiopulmonary Bypass

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Postoperative chest drainage volume

Secondary Outcome Measures:
  • Requirement for perioperative blood product transfusion
  • Incidence of complications after surgery

Estimated Enrollment: 160
Study Start Date: April 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
  • Willing to receive allogeneic blood product transfusions during and after surgery

Exclusion Criteria:

  • Have had previous cardiac surgery
  • Have had previous median sternotomy
  • Have tendency for bleeding or family history of bleeding
  • Have an abnormally low platelet count
  • Have received certain anticoagulant or antiplatelet medications within a specified time period prior to the scheduled CABG surgery
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Please refer to this study by its identifier: NCT00316212

  Show 27 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00316212     History of Changes
Other Study ID Numbers: 025-102
Study First Received: April 18, 2006
Last Updated: November 17, 2016

Keywords provided by Merck Sharp & Dohme Corp.:
Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
INS 50589
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017