Coronary Artery DiseasePhase 4NCT00476944
Comparing Bivalirudin Versus Heparin/ GP IIB/IIA in Patients Undergoing PCI
A Phase 4 study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease, run by Gold, Herman K., MD at 1 site in United States.
Trial summary
The purpose of this study is to compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to not given
- Phase
- Phase 4
- 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
- Patients must meet ALL of the following criteria:
- The patients must be >18 years of age
- Patients must have been referred for percutaneous coronary intervention (PCI)
- Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
- Treatment of lesions in native coronary vessels or bypass grafts requiring angioplasty or stenting.
- Patient is willing to comply with the specified follow-up evaluation;
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board.
Who cannot join
- Patients will be excluded if ANY of the following conditions apply:
- Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
- Active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding within past 6 weeks; prior intracranial bleeding; or platelet count<100,000
- Woman of child-bearing potential unless demonstrated negative pregnancy test
- End Stage Renal Disease requiring hemodialysis
- Recipient of heart transplant;
Show all 15Show fewer
- Current treatment with 1) intravenous unfractionated heparin or treatment with low molecular weight heparin within past 8 hours; 2)bivalirudin; 3)abciximab; 4)eptifibatide; or tirofiban
- Ongoing need for warfarin or heparin therapy
- Known allergies to aspirin, clopidogrel bisulfate (Plavix®) and/or heparin;
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another device study;
- Any contraindication to glycoprotein IIb/IIIa inhibitor (eptifibatide (Integrilin®)) or bivalirudin therapy;
- Chronic or relapse/remitting hemolytic condition or pre-catheterization hematocrit<30 mg/dl
- Unprotected left main coronary disease with >50% stenosis;
- Platelet count <150,000
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Herman K Gold, MD
Aloke V Finn, MD
About this study
Official title: Minimizing Post-Procedural Vascular Complications: Comparing Bivalirudin Versus Heparin/GP IIB/IIA in Patients Undergoing Percutaneous Coronary Intervention
The purpose of this study is to compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use.
Read the detailed description
Anti-thrombotic therapies have enhanced the safety of percutaneous coronary intervention (PCI). In addition to aspirin, heparin and platelet glycoprotein (Gp) IIB/IIIA receptor inhibition have been used as the reference strategy to reduce the incidence of ischemic complications during coronary interventions 1. However, the success of this strategy is limited by increased bleeding risk, prolonged drug infusions (12 hours), and patient inconveniences (such as lying flat for hours until blood coagulation becomes normal and sheaths can be safely removed). Peri-procedural bleeding due to vascular complications is one of the most frequent complications of PCI and is associated with adverse events 2.
Newer anti-thrombotic strategies may further improve outcomes after PCI. The efficacy of a direct thrombin inhibitor bivalirudin (Angiomax™) was investigated in a randomized controlled clinical trial as a replacement for the strategy of heparin/Gp IIB/IIIA inhibition in patients undergoing coronary intervention. The REPLACE-2 study, which randomized over 6000 patients found short and long-term clinical outcomes with bivalirudin were as effective as heparin/Gp IIB/IIIA inhibition combination with evidence of significantly less major and minor bleeding 3, 4. This led to approval of the 0.75 mg/kg/1.75 mg/kg/hr dose of Angiomax® by the Food and Drug Administration for use as an anticoagulant in patients with unstable angina undergoing PCI.
It is now routinely accepted that early sheath removal after PCI reduces femoral access site complications and leads to earlier ambulation, earlier discharge, improved patient satisfaction 5. Heparin-based anticoagulation requires monitoring of the coagulation status to determine readiness for sheath removal because of the lack of predictable duration of anticoagulation with heparin. Because clearance of bivalirudin occurs mostly by proteolytic cleavage by thrombin, the drug has more predictable pharmacokinetics and exhibits linear dose relationship with respect to plasma concentrations and coagulation assay endpoints 6. Preliminary studies indicate sheath removal 2 hours after cessation of bivalirudin without coagulation monitoring is safe 5. While REPLACE-2 suggested that catheterization related vascular complications were decreased with bivalirudin, specific data on these endpoints and others such as time to ambulation and time to discharge were not collected because of the blinded nature of the trial. Currently the rate of vascular complications at MGH for patients undergoing PCI is 4.0% which significantly exceeds the national rate of 1.9% (95% CI 1.1 to 3.2) 7.
We will conduct a randomized clinical trial in patients undergoing PCI to compare the rates of vascular related complications between patients assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use. The primary endpoint will be a composite of vascular related groin complications (MAVE-major adverse vascular endpoints as defined in next section). Secondary endpoints will be 1) time to sheath pull; 2) time to ambulation; and 3) occurrence of major and minor bleeding peri-catheterization.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- CAD, Coronary Artery Disease, Angiomax, Bivalirudin, PCI, MAVE, Heparin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who require a vascular groin ultrasound or abdominal CT.
Record occurrence of pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or femoral vein or arterial thrombosis
Record presence of hematoma and size if applicable.
Record hemoglobin drop >3g/dl with over bleeding. Also, record any red cell transfusion due to catheterization related bleeding.
Secondary outcomes (3)
Comparison of time to ambulation.
Occurrence of major and minor bleeding peri-catheterization.
Observe incidence of thrombocytopenia post catheterization defined as a platelet count <100,000.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gold, Herman K., MD
- Collaborators
- The Medicines Company
- Investigators
- Herman K Gold, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476944
- Sponsor's protocol ID
- 2006P000944
- Status last verified
- May 2007
- First submitted
- 18 May 2007
- Last updated
- 22 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Post-Procedural Vascular Complications: Comparing Bivalirudin Versus Heparin/GP IIB/IIA in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00476944
- Acronym / sponsor ID
- 2006P000944
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, Coronary Artery Disease, Angiomax, Bivalirudin, PCI, MAVE, Heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gold, Herman K., MD
- Collaborators
- The Medicines Company
- Study start
- Sep 2006
- First posted
- 22 May 2007 (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 compare the rates of vascular related complications in patients undergoing percutaneous coronary intervention assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use.
Detailed description
Anti-thrombotic therapies have enhanced the safety of percutaneous coronary intervention (PCI). In addition to aspirin, heparin and platelet glycoprotein (Gp) IIB/IIIA receptor inhibition have been used as the reference strategy to reduce the incidence of ischemic complications during coronary interventions 1. However, the success of this strategy is limited by increased bleeding risk, prolonged drug infusions (12 hours), and patient inconveniences (such as lying flat for hours until blood coagulation becomes normal and sheaths can be safely removed). Peri-procedural bleeding due to vascular complications is one of the most frequent complications of PCI and is associated with adverse events 2.
Newer anti-thrombotic strategies may further improve outcomes after PCI. The efficacy of a direct thrombin inhibitor bivalirudin (Angiomax™) was investigated in a randomized controlled clinical trial as a replacement for the strategy of heparin/Gp IIB/IIIA inhibition in patients undergoing coronary intervention. The REPLACE-2 study, which randomized over 6000 patients found short and long-term clinical outcomes with bivalirudin were as effective as heparin/Gp IIB/IIIA inhibition combination with evidence of significantly less major and minor bleeding 3, 4. This led to approval of the 0.75 mg/kg/1.75 mg/kg/hr dose of Angiomax® by the Food and Drug Administration for use as an anticoagulant in patients with unstable angina undergoing PCI.
It is now routinely accepted that early sheath removal after PCI reduces femoral access site complications and leads to earlier ambulation, earlier discharge, improved patient satisfaction 5. Heparin-based anticoagulation requires monitoring of the coagulation status to determine readiness for sheath removal because of the lack of predictable duration of anticoagulation with heparin. Because clearance of bivalirudin occurs mostly by proteolytic cleavage by thrombin, the drug has more predictable pharmacokinetics and exhibits linear dose relationship with respect to plasma concentrations and coagulation assay endpoints 6. Preliminary studies indicate sheath removal 2 hours after cessation of bivalirudin without coagulation monitoring is safe 5. While REPLACE-2 suggested that catheterization related vascular complications were decreased with bivalirudin, specific data on these endpoints and others such as time to ambulation and time to discharge were not collected because of the blinded nature of the trial. Currently the rate of vascular complications at MGH for patients undergoing PCI is 4.0% which significantly exceeds the national rate of 1.9% (95% CI 1.1 to 3.2) 7.
We will conduct a randomized clinical trial in patients undergoing PCI to compare the rates of vascular related complications between patients assigned to one of two arms: 1) bivalirudin + provisional Gp IIB/IIIA use versus 2) heparin + Gp IIB/IIIA (eptifibatide (Integrilin®)) use. The primary endpoint will be a composite of vascular related groin complications (MAVE-major adverse vascular endpoints as defined in next section). Secondary endpoints will be 1) time to sheath pull; 2) time to ambulation; and 3) occurrence of major and minor bleeding peri-catheterization.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patients must be >18 years of age
- Patients must have been referred for percutaneous coronary intervention (PCI)
- Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
- Treatment of lesions in native coronary vessels or bypass grafts requiring angioplasty or stenting.
- Patient is willing to comply with the specified follow-up evaluation;
Key exclusion criteria (15 listed)
- Patient has experienced an ST-segment elevation myocardial infarction within the preceding 24 hours.
- Active internal bleeding or bleeding diathesis, surgery, trauma, or gastrointestinal or genitourinary tract bleeding within past 6 weeks; prior intracranial bleeding; or platelet count<100,000
- Woman of child-bearing potential unless demonstrated negative pregnancy test
- End Stage Renal Disease requiring hemodialysis
- Recipient of heart transplant;
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI) | Procedure or surgery | – |
Primary outcome
Number of patients who require a vascular groin ultrasound or abdominal CT.
Record occurrence of pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or femoral vein or arterial thrombosis
Record presence of hematoma and size if applicable.
Record hemoglobin drop >3g/dl with over bleeding. Also, record any red cell transfusion due to catheterization related bleeding.
3 secondary outcomes
Comparison of time to ambulation.
Occurrence of major and minor bleeding peri-catheterization.
Observe incidence of thrombocytopenia post catheterization defined as a platelet count <100,000.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2007.
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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.
Herman K Gold, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous Coronary Intervention (PCI) in people with Coronary Artery Disease, run by Gold, Herman K., MD 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 7 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: status not confirmed, as of the sponsor's last update on 22 May 2007. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maureen Daher, RN (617-726-7400, MDAHER@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who require a vascular groin ultrasound or abdominal CT.. 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 22 May 2007.