Cardiovascular DiseasePhase 3NCT00079586
Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
A Phase 3 study testing Heparin and Bivalirudin in people with Cardiovascular Disease and Coronary Artery Bypass Surgery, run by The Medicines Company at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Coronary Artery Bypass Surgery
- What is being tested?
- Heparin and Bivalirudin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Nov 2004
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Be scheduled for CABG, CABG and single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study.
Who cannot join
- Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
- Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30 mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.
- Patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline INR is < 1.3 times control in the absence of heparin therapy.
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- Known allergy to Angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
- Patients receiving clopidogrel (Plavix®) within the previous 5 days of randomization
- Patients receiving a glycoprotein IIb/IIIa inhibitor within the previous 48 hours if abciximab (ReoPro®) or 24 hours if eptifibatide (Integrilin®) or tirofiban (Aggrastat®) of randomization.
- Patients receiving lepirudin (Refludan®) or argatroban within the previous 24 hours prior to randomization.
- Patients receiving LMWH or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
- Refusal to undergo blood transfusion should it become necessary.
- Any other disease or condition, which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
- Planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
- Planned (>1) double (or greater) valve repair-replacement (e.g.: AVR-MVR) surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
- Being tested
- Heparin, Bivalirudin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Unfractionated Heparin per institutional practice
BivalirudinDrug
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Heparin | Active comparator | unfractionated heparin will be administered as per institutional practice Receives: Drug: Heparin |
| Angiomax | Experimental | 1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion Receives: Drug: Bivalirudin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2004 (estimated)
- Study startApr 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malcolm Lloyd, MD, Study director, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079586
- Sponsor's protocol ID
- TMC-BIV-02-06
- Other IDs
- EVOLUTION-On
- Status last verified
- Jan 2012
- First submitted
- 9 Mar 2004
- Last updated
- 5 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT00079586
- Acronym / sponsor ID
- TMC-BIV-02-06
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Nov 2004 (actual)
- First posted
- 11 Mar 2004 (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 study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin | Active comparator | Drug: Heparinunfractionated heparin will be administered as per institutional practice |
| Angiomax | Experimental | Drug: Bivalirudin1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Be scheduled for CABG, CABG and single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eligible for this study.
Key exclusion criteria (16 listed)
- Confirmed pregnancy at time of randomization via IVRS (if woman of child-bearing potential) (Urine or serum pregnancy test)
- Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30 mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.
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 |
|---|---|---|
| HeparinUnfractionated Heparin per institutional practice | Drug | Heparin |
| Bivalirudin1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion | Drug | Angiomax |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
Malcolm Lloyd, MD study director
The Medicines Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin and Bivalirudin in people with Cardiovascular Disease and Coronary Artery Bypass Surgery, run by The Medicines Company at 1 site 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 5 Jan 2012.