Heparin-Induced ThrombocytopeniaPhase 4NCT00759083
Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
A Phase 4 study testing bivalirudin in people with Heparin-Induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis Syndrome, run by The Medicines Company at 1 site in United States.
Trial summary
To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome
- What is being tested?
- bivalirudin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to 10 May 2010
- 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
- Clinically Documented History of HIT/HITTS
- Suspicion of HIT/HITTS
Who cannot join
- Bleeding Diathesis
- Ischemic Stroke
- Chronic Thrombocytopenia
- Hematologic Malignancy
- Contraindication to bivalirudin
- Pregnant or nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27705
About this study
Official title: Bivalirudin PCI Registry in HIT/HITTS Patients
To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention
- Conditions
- Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome
- Being tested
- bivalirudin
- Keywords
- HIT, HITTS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalirudinDrug
Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with HIT/HITTS who require anticoagulation for PCI Receives: Drug: bivalirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet counts
Measured: 6, 12, 24, 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completion10 May 2010
Why it stopped: The study was discontinued early due to inadequate patient enrollment. No patients were enrolled.
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magnus Ohman, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759083
- Sponsor's protocol ID
- TMC-BIV-07-02
- Status last verified
- Oct 2020
- First submitted
- 22 Sep 2008
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bivalirudin PCI Registry in HIT/HITTS Patients
- ClinicalTrials.gov ID
- NCT00759083
- Acronym / sponsor ID
- TMC-BIV-07-02
- Conditions
- Heparin-Induced Thrombocytopenia, Heparin-induced Thrombocytopenia and Thrombosis Syndrome
- Keywords
- HIT, HITTS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was discontinued early due to inadequate patient enrollment. No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- 10 May 2010 (actual)
- First posted
- 25 Sep 2008 (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.
To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bivalirudinPatients with HIT/HITTS who require anticoagulation for PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically Documented History of HIT/HITTS
- Suspicion of HIT/HITTS
Key exclusion criteria (6 listed)
- Bleeding Diathesis
- Ischemic Stroke
- Chronic Thrombocytopenia
- Hematologic Malignancy
- Contraindication to bivalirudin
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; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure | Drug | 1 |
Primary outcome
Platelet counts
Time frame: 6, 12, 24, 48 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Related trials for Heparin-Induced Thrombocytopenia
Not yet recruitingObservational study
Cangrelor As Treatment for Cardiac Surgery Associated With Heparin Induced Thrombocytopenia
Heparin-induced Thrombocytopenia
Recruiting
Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia
Heparin-induced Thrombocytopenia, HIT
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.
Magnus Ohman, MD principal investigator
Duke Clinical Research Institute
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 bivalirudin in people with Heparin-Induced Thrombocytopenia and Heparin-induced Thrombocytopenia and Thrombosis Syndrome, 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Platelet counts (time frame: 6, 12, 24, 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 19 Oct 2020.