Coronary DiseasePhase 2NCT00316212
Study of INS50589 Intravenous Infusion in Subjects Undergoing Coronary Artery Bypass Grafting (CABG) Involving Cardiopulmonary Bypass
A Phase 2 study testing INS50589 Intravenous Infusion in people with Coronary Disease, run by Merck Sharp & Dohme LLC at 27 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- INS50589 Intravenous Infusion
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 27 sitesUnited States
- Study dates
- Apr 2006to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
- Willing to receive allogeneic blood product transfusions during and after surgery
Who cannot join
- 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
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Baptist Medical Center Princeton
Birmingham, Alabama, 35211
Cardiology, P.C.
Birmingham, Alabama, 35211
Cardiac, Vascular, & Thoracic Surgeons, Inc.
Cincinnati, Ohio, 45209
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
Duke University Medical Center
Durham, North Carolina, 27710
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804
The Brody School of Medicine, East Carolina University
Greenville, North Carolina, 27834
The Methodist Hospital
Houston, Texas, 77030
CardioThoracic Surgery Center, PLC
Jackson, Tennessee, 38301
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Veterans Affairs Medical Center
Lexington, Kentucky, 40506
University of Kentucky, Chandler Medical Center
Lexington, Kentucky, 40536
Centennial Medical Center
Nashville, Tennessee, 37203
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, 73120
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Viahealth Rochester General Hospital
Rochester, New York, 14621
St. Mary's of Michigan
Saginaw, Michigan, 48601
Covenant Medical Center
Saginaw, Michigan, 48602
Sharp Memorial Hospital
San Diego, California, 92123
Memorial Medical Center
Springfield, Illinois, 62702
St. John's Hospital
Springfield, Illinois, 62769
Southern Illinois University School of Medicine
Springfield, Illinois, 62794-9638
FHS Research Center, St. Joseph Medical Center
Tacoma, Washington, 98405
Northwest Cardiovascular Associates
Tacoma, Washington, 98405
Winchester Medical Center
Winchester, Virginia, 22601
About this study
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
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.
- Conditions
- Coronary Disease
- Being tested
- INS50589 Intravenous Infusion
- Keywords
- Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS50589 Intravenous InfusionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chest drainage volume
Secondary outcomes (2)
Requirement for perioperative blood product transfusion
Incidence of complications after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316212
- Sponsor's protocol ID
- 025-102
- Status last verified
- Nov 2016
- First submitted
- 18 Apr 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00316212
- Acronym / sponsor ID
- 025-102
- Conditions
- Coronary Disease
- Keywords
- Coronary Artery Bypass Graft Surgery involving Cardiopulmonary Bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 160 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- First posted
- 20 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are scheduled for primary CABG by median sternotomy involving cardiopulmonary bypass
- Willing to receive allogeneic blood product transfusions during and after surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS50589 Intravenous Infusion | Drug | – |
Primary outcome
Postoperative chest drainage volume
2 secondary outcomes
Requirement for perioperative blood product transfusion
Incidence of complications after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INS50589 Intravenous Infusion in people with Coronary Disease, run by Merck Sharp & Dohme LLC at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative chest drainage volume. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.