Heparin-Induced ThrombocytopeniaPhase 3NCT00043940
Anticoagulant Therapy With Bivalirudin in the Performance of Percutaneous Coronary Intervention in Patients With Heparin-Induced Thrombocytopenia (AT BAT, First Inning)
A Phase 3 study testing bivalirudin in people with Heparin-Induced Thrombocytopenia and Thrombosis, run by The Medicines Company at 1 site in United States.
Trial summary
Primary Objective: To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia, Thrombosis
- What is being tested?
- bivalirudin
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Feb 2003
- 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
- Males and females at least 18 years of age,
- Be able to provide written informed consent,
- Need anticoagulation for percutaneous coronary intervention (angioplasty, rotational atherectomy, directional coronary atherectomy, transluminal extraction catheter, or coronary stent),
- New diagnosis or history of clinically suspected or objectively documented HIT/HITTS, defined as:
- Positive heparin-induced platelet aggregation (HIPA) or other functional assay, defined as: (B) HIT: Thrombocytopenia associated with heparin therapy, where the platelet count: (i) has decreased to <100x10(9)/L (minimum of 30% drop from the platelet count before heparin treatment), OR (ii) has decreased to <150x10(9)/L (minimum of 40% drop from the platelet count before heparin treatment, OR, (C) HITTS: Thrombocytopenia (as defined above) PLUS arterial or venous thrombosis (deep-vein thrombosis, pulmonary embolism, mesenteric venous or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion or limb arteries), diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venous or arterial angiography, MRI/MRA, catheterization).
Who cannot join
- Overt or known active significant bleeding,
- Definitive evidence of an alternative explanation for the thrombocytopenia (e.g.m DIC, sepsis, other consumptive coagulopathy, ITP, TTP, HUS, or bone-marrow failure),
- Coagulation disorder or bleeding diathesis unrelated to HIT/HITTS,
- Patients with renal impairment, defined as calculated creatinine clearance <30 mL/min, or any other medical conditions (including hepatic, pulmonary, gastrointestinal, endocrine, or psychiatric) that, in the investigator's opinion, would endanger the patient if she/he receives anticoagulant therapy,
- Nonhemorrhagic stroke within the past 6 months or any previous hemorrhagic stroke,
- Intracranial neoplasm, or cerebral/spinal arteriovenous malformation or aneurysm,
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- Lumbar puncture, or spinal/epidural catheter placement within the past 7 days,
- Known prior hemorrhage (gastrointestinal, genitourinary, pericardia, pleural, retroperitoneal spaces), major surgery, or serious trauma within the past 6 weeks, unless attending physician believes the need for anticoagulation with PCI outweighs the potential bleeding risk,
- Puncture of a non-compressible vessel within 24 hours before the planned PCI,
- Confirmed uncontrolled hypertension (systolic blood pressure > or = 100 mmHg) at study entry,
- Ongoing anticoagulant therapy at study entry. However, patients may be entered if the therapy can be safely stopped periprocedurally, or, in the case of oral warfarin, if the prothrombin time INR can safely be brought to < or = 1.5 just before study drug infusion,
- Known or suspected pregnancy, or breast-feed. Women of childbearing potential must have a negative pregnancy test (urine or blood) and must be made explicitly aware that bivalirudin may cause excessive menstrual bleeding. Known or suspected pregnancy, or breast-feeding,
- Known hypersensitivity to bivalirudin or leech proteins,
- If the patient has participated in a drug trial within the past 48 hour, call the DCRI hotline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute, Duke University Medical Center
Durham, North Carolina
About this study
Official title: Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia
Primary Objective:
To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%.
Read more
Secondary Objectives:
Each component of the primary composite endpoint.
To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion.
To evaluate bivalirudin's effects on platelet counts.
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis
- Being tested
- bivalirudin
- Keywords
- thrombosis, bivalirudin, direct thrombin inhibitor, HIT, HITTS, HIT/HITTS
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
Bivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding events
composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2002 (estimated)
- Study startApr 1999
- Primary completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heparin-Induced ThrombocytopeniaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043940
- Sponsor's protocol ID
- TMC-98-10
- Status last verified
- Sep 2011
- First submitted
- 14 Aug 2002
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant Therapy With Bivalirudin in the Performance of PCI in Patients With Heparin-Induced Thrombocytopenia
- ClinicalTrials.gov ID
- NCT00043940
- Acronym / sponsor ID
- TMC-98-10
- Conditions
- Heparin-Induced Thrombocytopenia, Thrombosis
- Keywords
- thrombosis, bivalirudin, direct thrombin inhibitor, HIT, HITTS, HIT/HITTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Feb 2003 (actual)
- First posted
- 16 Aug 2002 (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.
Primary Objective:
To assess the safety of bivalirudin as an alternative anticoagulant therapy for patients with new or previous heparin-induced thrombocytopenia (HIT) / heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing percutaneous coronary intervention (PCI). This will be measured by the composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin (or at hospital discharge, whichever occurs first). The components of the composite endpoint are: a) intracranial bleeding; b) retroperitoneal bleeding; c) bleeding that results in hemodynamic compromise; d) bleeding that requires transfusion of three or more units of whole blood or packed red cells; and e) a decrease in hemoglobin of greater than or equal to g/dL or in hematocrit of greater than or equal to 9%.
Secondary Objectives:
Each component of the primary composite endpoint.
To evaluate the level of anticoagulation achieved with bivalirudin. The goal is to achieve an activated clotting time (ACT) between 300 and 350 sec during PCI and 4-hour bivalirudin infusion.
To evaluate bivalirudin's effects on platelet counts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (5 listed)
- Males and females at least 18 years of age,
- Be able to provide written informed consent,
- Need anticoagulation for percutaneous coronary intervention (angioplasty, rotational atherectomy, directional coronary atherectomy, transluminal extraction catheter, or coronary stent),
- New diagnosis or history of clinically suspected or objectively documented HIT/HITTS, defined as:
- Positive heparin-induced platelet aggregation (HIPA) or other functional assay, defined as: (B) HIT: Thrombocytopenia associated with heparin therapy, where the platelet count: (i) has decreased to <100x10(9)/L (minimum of 30% drop from the platelet count before heparin treatment), OR (ii) has decreased to <150x10(9)/L (minimum of 40% drop from the platelet count before heparin treatment, OR, (C) HITTS: Thrombocytopenia (as defined above) PLUS arterial or venous thrombosis (deep-vein thrombosis, pulmonary embolism, mesenteric venous or arterial thrombosis, acute myocardial infarction, left ventricular thrombus, ischemic stroke, or occlusion or limb arteries), diagnosed by physical exam/lab evidence and/or appropriate imaging studies (duplex ultrasound, venography, ventilation-perfusion scan, venous or arterial angiography, MRI/MRA, catheterization).
Key exclusion criteria (14 listed)
- Overt or known active significant bleeding,
- Definitive evidence of an alternative explanation for the thrombocytopenia (e.g.m DIC, sepsis, other consumptive coagulopathy, ITP, TTP, HUS, or bone-marrow failure),
- Coagulation disorder or bleeding diathesis unrelated to HIT/HITTS,
- Patients with renal impairment, defined as calculated creatinine clearance <30 mL/min, or any other medical conditions (including hepatic, pulmonary, gastrointestinal, endocrine, or psychiatric) that, in the investigator's opinion, would endanger the patient if she/he receives anticoagulant therapy,
- Nonhemorrhagic stroke within the past 6 months or any previous hemorrhagic stroke,
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 |
|---|---|---|
| bivalirudinBivalirudin therapy will be given as a 0.75-mg/kg intravenous bolus and 1.75-mg/kg/h intravenous infusion during procedure and up to 4 hours. | Drug | – |
Primary outcome
Major bleeding events
Time frame: 48 hours
composite incidence of major bleeding events during administration or within 48 hours after stopping bivalirudin
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 16 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Heparin-Induced Thrombocytopenia and Thrombosis, 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 5 inclusion and 14 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 16 Sep 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?
Major bleeding events (time frame: 48 hours). 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 16 Sep 2011.