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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00316212
First Posted: April 20, 2006
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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
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)
  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT00316212


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00316212     History of Changes
Other Study ID Numbers: 025-102
First Submitted: April 18, 2006
First Posted: April 20, 2006
Last Update Posted: November 18, 2016
Last Verified: November 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
Arteriosclerosis
Arterial Occlusive Diseases
INS 50589
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs