Cardiac SurgeryPhase 3OPCABNCT00073593
Comparing Angiomax to Heparin With Protamine Reversal in Patients OPCAB
A Phase 3 study testing Bivalirudin, Heparin and Protamine in people with Cardiac Surgery 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 examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Surgery, Coronary Artery Bypass Surgery
- What is being tested?
- Bivalirudin, Heparin and Protamine
- 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
- Aug 2003to May 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
- Healthy volunteers accepted
- 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 accepted for elective off-pump coronary artery bypass graft (CABG) surgery without concomitant cardiac surgical procedures.
- < 4 planned Coronary Artery Bypass Grafts
Who cannot join
- Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
- Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of childbearing potential).
- Cerebrovascular accident within 6 months before randomization, or any cerebrovascular accident with residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30mL/min.
- Ongoing treatment with warfarin (or other oral anticoagulants) 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 these products.
- Patients receiving clopidogrel within the previous 5 days of randomization.
- Patients receiving a glycoprotein IIb/IIIa inhibitor within 48 hours if abciximab (ReoPro) or within 24 hours if eptifibatide (Integrilin) and tirofiban (Aggrastat) of randomization
- Patients receiving lepirudin or argatroban within the previous 24 hours of randomization.
- Patients receiving low molecular weight heparin (LMWH) or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
- Patients with active or prior history of heparin-induced thrombocytopenia (HIT)/heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)*.
- 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 inability to comply with study requirements.
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 Coronary Artery Bypass (OPCAB) Surgery
The purpose of this study is to examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Surgery
- Being tested
- Bivalirudin, Heparin, Protamine
- Keywords
- Off-Pump Coronary Artery Bypass Graft Surgery, CABG, OPCAB, Heparin, Patients requiring off-pump CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BivalirudinDrug
250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s).
HeparinDrug
: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock.
ProtamineDrug
Per institutional practice. Batches from hospital stock.
| Study group | Role | What they receive |
|---|---|---|
| bivalirudin | Experimental | 250mg vial given as 0.75mg/kg intravenous (IV) bolus and 1.75 mg/kg/hr IV infusion for the duration of the procedure with the option to increase or decrease the infusion in 0.25 mg/kg/hr increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an ACT>300 seconds. Receives: Drug: Bivalirudin |
| heparin/protamine | Active comparator | 1.5-3.5 mg/kg (200-400 U/kg) intravenous (IV) bolus to target an ACT >300 seconds followed by weight-adjusted boluses as needed during the procedure to achieve/maintain the target ACT. Protamine as needed Receives: Drug: Heparin; Drug: Protamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: Hospital discharge or Day 7
Q-wave MI
Measured: hospital discharge or day 7,
Repeat Coronary Revascularization,
Measured: hospital discharge or day 7,
Stroke (hemorrhagic or ischemic).
Measured: hospital discharge or day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2003 (estimated)
- Study startAug 2003
- Primary completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- Andrew Sternlicht, MD, Study director, The Medicines Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073593
- Sponsor's protocol ID
- TMC-BIV-02-07
- Other IDs
- EVOLUTION
- Acronym
- OPCAB
- Status last verified
- Nov 2011
- First submitted
- 26 Nov 2003
- Last updated
- 10 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. 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 Coronary Artery Bypass (OPCAB) Surgery
- ClinicalTrials.gov ID
- NCT00073593
- Acronym / sponsor ID
- OPCAB / TMC-BIV-02-07
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Surgery
- Keywords
- Off-Pump Coronary Artery Bypass Graft Surgery, CABG, OPCAB, Heparin, Patients requiring off-pump CABG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- May 2004 (actual)
- First posted
- 27 Nov 2003 (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 examine the safety and efficacy of Angiomax as an alternative anticoagulant to heparin with protamine reversal in patients undergoing off-pump coronary artery bypass graft surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bivalirudin | Experimental | Drug: Bivalirudin250mg vial given as 0.75mg/kg intravenous (IV) bolus and 1.75 mg/kg/hr IV infusion for the duration of the procedure with the option to increase or decrease the infusion in 0.25 mg/kg/hr increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an ACT>300 seconds. |
| heparin/protamine | Active comparator | Drug: Heparin, Drug: Protamine1.5-3.5 mg/kg (200-400 U/kg) intravenous (IV) bolus to target an ACT >300 seconds followed by weight-adjusted boluses as needed during the procedure to achieve/maintain the target ACT. Protamine as needed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Be accepted for elective off-pump coronary artery bypass graft (CABG) surgery without concomitant cardiac surgical procedures.
- < 4 planned Coronary Artery Bypass Grafts
Key exclusion criteria (15 listed)
- Any prior Cardio-Thoracic Surgical procedures requiring median sternotomy
- Confirmed pregnancy - baseline urine or serum pregnancy test (if woman of childbearing potential).
- Cerebrovascular accident within 6 months before randomization, or any cerebrovascular accident with residual neurological deficit.
- Intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Dependency on renal dialysis or creatinine clearance <30mL/min.
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 |
|---|---|---|
| Bivalirudin250 mg vial administered as 0.75 mg/kg intravenous (IV) bolus and 1.75 mg/kg/h IV infusion for the duration of surgery with the option to increase or decrease the infusion in 0.25 mg/kg/h increments or to administer additional 0.1-0.5 mg/kg boluses to maintain an activated clotting time (ACT) >300 seconds (s). | Drug | bivalirudin |
| Heparin: Per institutional practice, at 1.5-3.5 mg/kg (200-400 U/kg) IV bolus to achieve a target ACT of >300 s followed by weight-adjusted boluses as needed during surgery to achieve/maintain the target ACT. Batches from hospital stock. | Drug | heparin/protamine |
| ProtaminePer institutional practice. Batches from hospital stock. | Drug | heparin/protamine |
Primary outcome
Death
Time frame: Hospital discharge or Day 7
Q-wave MI
Time frame: hospital discharge or day 7,
Repeat Coronary Revascularization,
Time frame: hospital discharge or day 7,
Stroke (hemorrhagic or ischemic).
Time frame: hospital discharge or day 7
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 10 Nov 2011.
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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.
Andrew Sternlicht, 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 Bivalirudin, Heparin and Protamine in people with Cardiac Surgery 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 4 inclusion and 15 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 10 Nov 2011. 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.
What does the primary outcome measure?
Death (time frame: Hospital discharge or Day 7). The study lists 4 primary outcomes in all. 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 10 Nov 2011.