Suspected Heparin-Induced ThrombocytopeniaPhase 4HITNCT00787332
A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
A Phase 4 study testing Desirudin or Argatroban® in people with Suspected Heparin-Induced Thrombocytopenia, run by Canyon Pharmaceuticals, Inc. at 24 sites in United States.
Trial summary
Compare Clinical Success and Costs in two Arms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Heparin-Induced Thrombocytopenia
- What is being tested?
- Desirudin or Argatroban®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 24 sitesUnited States
- Study dates
- Sep 2008to Dec 2009
- 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
- Provide written Informed Consent
- Be at least 18 years of age.
- A suspicion of heparin-induced thrombocytopenia with or without thrombosis syndrome (HIT/TS) due to one of the following clinical scenarios:
- Patients who are receiving heparin/LMWH or have received heparin/LMWH within the previous 100 days AND one of the following:
- have a fall in platelet count of > 30% from a baseline prior to heparin/LMWH, OR
- have a thrombotic event, OR
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- develop skin lesions secondary to subcutaneous heparin (even if the patient is no longer receiving heparin therapy when thrombocytopenia, thrombosis or skin lesions occur).
- Patients with thrombosis or skin lesions need not have concomitant thrombocytopenia to be included.
- A rapid fall in the platelet count by >30% from baseline within 24 hours after starting heparin/LMWH in patients with suspected exposure to heparin or LMWH in the previous 100 days (e.g. hospitalization or invasive procedure within the past 100 days).
- In post-operative cardiac surgery patients, development of thrombocytopenia defined as a decrease in platelet count by >30% from the post-operative peak; or patients whose platelet count fails to increase post-operatively (e.g. remains < 100,000 mm3 at Day 4 or later, calendar day of surgery=Day 0).
- In patients with the diagnosis of HIT/TS established by a hematology consultant, but in whom the above criteria are not fulfilled, the Investigator should contact the Medical Monitor for consideration of the patient's inclusion in this study (A hematology consult is highly advisable, but not required prior to randomization).
Who cannot join
- Confirmed pregnancy (if woman of child-bearing potential- urine or serum pregnancy test).
- Patients with suspected or confirmed pulmonary embolism, requiring continued anticoagulation or acute ischemic stroke will be excluded
- Cerebrovascular accident within the previous 6 months
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- Severe renal insufficiency as determined by measured or estimated creatinine clearance < 30 ml/min.
- Known allergy to Argatroban®, Desirudin or hirudin derived drugs, or known sensitivity to any component of the product
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- Patients receiving recombinant hirudin (e.g. lepirudin) within the previous 6 months prior to enrollment.
- Patients receiving >2 doses of fondaparinux for treatment of suspected HIT
- Multi-system organ failure or estimated survival of less than 30 days.
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
- Refusal to undergo blood transfusion should it become necessary
- Active bleeding or irreversible coagulation abnormality
- Uncontrolled hypertension defined as a blood pressure >180/110 mm Hg.
- Patients requiring indwelling mechanical intervention such as left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration, etc.
- Severe liver disease and 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 cause inability to comply with the trial.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Emory University, Emory Crawford Long Hospital
Atlanta, Georgia, 30308
University of Colorado Health Science Center
Aurora, Colorado, 80045
Charleston Area Medical Center
Charleston, West Virginia, 25304
The Cleveland Clinic
Cleveland, Ohio, 44195
Cardiothoracic Vascular Surgial Specialists
Columbus, Ohio, 42314
The Ohio State University Medical Center
Columbus, Ohio, 43210
Kaiser Permanente Medical Center
Honolulu, Hawaii, 96819
Methodist Hospital
Houston, Texas, 77030
Provena St. Joseph's Medical Center
Joliet, Illinois, 60435
North Shore University Hospital
Manhasset, New York, 11030
St Vincent's Hosptial -Manhattan
Manhattan, New York, 10011
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Mount Sinai Clinical & Translational Research Institute
New York, New York, 10029
Florida Hospital Cardiovascular Research
Orlando, Florida, 32801
Maine Medical Center
Portland, Maine, 04102
St Mary's Hospital Rochester, Mayo Clinic
Rochester, Minnesota, 55902
University of Rochester Medical Center
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of Utah Hospital
Salt Lake City, Utah, 84132
Mercy Medical Center
Sioux City, Iowa, 51101
University of South Florida, Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center, Moses Division
The Bronx, New York, 10467
Washington Regional Cardiac Surgery
Washington D.C., District of Columbia, 20010
Forsyth Regional Medical Center
Winston-Salem, North Carolina, 55902
About this study
Official title: A Comparative Clinical and Pharmacoeconomic Study Comparing Argatroban® IV vs Desirudin SC for Patients With Suspected Heparin-Induced Thrombocytopenia (HIT)With or Without Thrombosis Syndrome (HIT/TS)
Compare Clinical Success and Costs in two Arms
Read the detailed description
Demonstrate clinical and economic utility between the study Arms.
- Being tested
- Desirudin or Argatroban®
- Keywords
- Suspected Heparin Induced Thrombocytopenia (HIT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desirudin or Argatroban®Drug
Desirudin 15mg SC Argatroban® IV dosing per Package Insert
| Study group | Role | What they receive |
|---|---|---|
| Desirudin | Experimental | Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin Receives: Drug: Desirudin or Argatroban® |
| Argatroban® | Active comparator | Patients randomized to IV Argatroban® Receives: Drug: Desirudin or Argatroban® |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Thrombosis, Amputation, Death, Major and Minor Bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Low enrollment
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suspected 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canyon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Bell, PharmD, Study director, Canyon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787332
- Sponsor's protocol ID
- DES-08-01
- Acronym
- HIT
- Status last verified
- Jan 2013
- First submitted
- 6 Nov 2008
- Last updated
- 10 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Boyce SW, Bandyk DF, Bartholomew JR, Frame JN, Rice L. A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study. Am J Ther. 2011 Jan;18(1):14-22. doi: 10.1097/MJT.0b013e3181f65503.
PubMed 21079512Frame JN, Rice L, Bartholomew JR, Whelton A. Rationale and design of the PREVENT-HIT study: a randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis. Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.
PubMed 20435232
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical and Pharmacoeconomic Study Comparing Argatroban® IV vs Desirudin SC for Patients With Suspected Heparin-Induced Thrombocytopenia (HIT)With or Without Thrombosis Syndrome (HIT/TS)
- ClinicalTrials.gov ID
- NCT00787332
- Acronym / sponsor ID
- HIT / DES-08-01
- Keywords
- Suspected Heparin Induced Thrombocytopenia (HIT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Canyon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 7 Nov 2008 (estimated)
- Results
- Posted 31 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare Clinical Success and Costs in two Arms
Detailed description
Demonstrate clinical and economic utility between the study Arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desirudin | Experimental | Drug: Desirudin or Argatroban®Patients with suspected HIT without thrombosis syndrome (HIT/TS), randomized to SC Desirudin |
| Argatroban® | Active comparator | Drug: Desirudin or Argatroban®Patients randomized to IV Argatroban® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written Informed Consent
- Be at least 18 years of age.
- A suspicion of heparin-induced thrombocytopenia with or without thrombosis syndrome (HIT/TS) due to one of the following clinical scenarios:
- Patients with thrombosis or skin lesions need not have concomitant thrombocytopenia to be included.
- In patients with the diagnosis of HIT/TS established by a hematology consultant, but in whom the above criteria are not fulfilled, the Investigator should contact the Medical Monitor for consideration of the patient's inclusion in this study (A hematology consult is highly advisable, but not required prior to randomization).
Key exclusion criteria (15 listed)
- Confirmed pregnancy (if woman of child-bearing potential- urine or serum pregnancy test).
- Patients with suspected or confirmed pulmonary embolism, requiring continued anticoagulation or acute ischemic stroke will be excluded
- Cerebrovascular accident within the previous 6 months
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- Severe renal insufficiency as determined by measured or estimated creatinine clearance < 30 ml/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 |
|---|---|---|
| Desirudin or Argatroban®Desirudin 15mg SC Argatroban® IV dosing per Package Insert | Drug | Argatroban®, Desirudin |
Primary outcome
New Thrombosis, Amputation, Death, Major and Minor Bleeding
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21079512Boyce SW, Bandyk DF, Bartholomew JR, Frame JN, Rice L. A randomized, open-label pilot study comparing desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis: PREVENT-HIT Study. Am J Ther. 2011 Jan;18(1):14-22. doi: 10.1097/MJT.0b013e3181f65503.
- Derived from this study: PubMed 20435232Frame JN, Rice L, Bartholomew JR, Whelton A. Rationale and design of the PREVENT-HIT study: a randomized, open-label pilot study to compare desirudin and argatroban in patients with suspected heparin-induced thrombocytopenia with or without thrombosis. Clin Ther. 2010 Apr;32(4):626-36. doi: 10.1016/j.clinthera.2010.04.012.
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.
Dawn Bell, PharmD study director
Canyon Pharmaceuticals, Inc.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desirudin or Argatroban® in people with Suspected Heparin-Induced Thrombocytopenia, run by Canyon Pharmaceuticals, Inc. at 24 sites 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 11 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: stopped early, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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 31 Dec 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?
New Thrombosis, Amputation, Death, Major and Minor Bleeding (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00787332, which also lists 2 linked publications.
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 Jan 2013.