Coronary Artery Bypass Graft SurgeryPhase 4NCT01246011
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
A Phase 4 study testing Argatroban and warfarin in people with Coronary Artery Bypass Graft Surgery and Presence of Heparin/Platelet Factor 4 Antibody, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery, Presence of Heparin/Platelet Factor 4 Antibody
- What is being tested?
- Argatroban and warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 scheduled for CABG (males or non-pregnant females)
- > 18 years old with at least one vein graft planned
- Able to provide written informed consent
Who cannot join
- Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
- Documented history of allergy to iodinated contrast media, warfarin, or argatroban
- Chronic renal impairment with CrCl<60 ml/min
- Recent bleeding episode
- Congestive Heart Failure (EF< 30%)
- Bleeding diathesis or known thrombophilic disorder
Show all 23Show fewer
- Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment
- Documented history of heparin induced thrombocytopenia
- Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count <100,000/ml
- Hepatic dysfunction (defined as LFTs > 3 times the upper limit of normal)
- Patients with a history of bleeding complications post-CABG
- Hemorrhagic stroke
- Gastrointestinal bleeding
- Requirement for fresh frozen plasma
- Recent central nervous system or ophthalmic surgery
- Aneurysm
- History of psychosis or senility
- Malignant hypertension
- Clinically significant pericarditis or pericardial effusion
- Bacterial endocarditis
- Hematocrit < 24%
- Valve replacement or repair at time of CABG
- Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02474
About this study
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.
Read the detailed description
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.
- Being tested
- Argatroban and warfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argatroban and warfarinDrug
Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.
| Study group | Role | What they receive |
|---|---|---|
| Heparin PF4 antibody positive -Drug (argatroban and warfarin) | Experimental | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin Receives: Drug: Argatroban and warfarin |
| Heparin PF4 antibody positive no drug | No intervention | Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication |
| Heparin PF4 antibody negative | No intervention | Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Bypass Vein Graft Patency
Vein graft patency as measured by computed tomography
Measured: Approximately 30 Days post CABG
Secondary outcomes (1)
Major Bleeding Events.
Intracranial bleed or any clinically overt sign of hemorrhage that is associated with a fall in hemoglobin > 5 g/dL.
Measured: At 2weeks post CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Enrollment was too slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246011
- Sponsor's protocol ID
- 2010P001386
- Status last verified
- Oct 2017
- First submitted
- 17 Nov 2010
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
- ClinicalTrials.gov ID
- NCT01246011
- Acronym / sponsor ID
- 2010P001386
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was too slow.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Posted 12 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and no signs or symptoms of Heparin Induced Thrombocytopenia (HIT) will be randomized to receive argatroban and warfarin. 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment. 30 subjects with a negative antibody result will also be followed in the study. All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts. This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts.
Detailed description
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups. An additional 30 patients with negative antibody titers will serve as a control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heparin PF4 antibody positive -Drug (argatroban and warfarin) | Experimental | Drug: Argatroban and warfarinPost-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin |
| Heparin PF4 antibody positive no drug | No intervention | –Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication |
| Heparin PF4 antibody negative | No intervention | –Post-CABG heparin PF4 antibody negative with no signs or symptoms of HIT randomized to receive no medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for CABG (males or non-pregnant females)
- > 18 years old with at least one vein graft planned
- Able to provide written informed consent
Key exclusion criteria (23 listed)
- Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
- Documented history of allergy to iodinated contrast media, warfarin, or argatroban
- Chronic renal impairment with CrCl<60 ml/min
- Recent bleeding episode
- Congestive Heart Failure (EF< 30%)
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 |
|---|---|---|
| Argatroban and warfarinSubjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month. | Drug | Heparin PF4 antibody positive -Drug (argatroban and warfarin) |
Primary outcome
Coronary Artery Bypass Vein Graft Patency
Time frame: Approximately 30 Days post CABG
Vein graft patency as measured by computed tomography
1 secondary outcome
Major Bleeding Events.
Time frame: At 2weeks post CABG
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ik-Kyung Jang, MD, PhD 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 Argatroban and warfarin in people with Coronary Artery Bypass Graft Surgery and Presence of Heparin/Platelet Factor 4 Antibody, run by Massachusetts General Hospital 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 23 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 17 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Coronary Artery Bypass Vein Graft Patency (time frame: Approximately 30 Days post CABG). 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 17 Nov 2017.