Polycythemia VeraPhase 2ISCLAPNCT00940784
Clopidogrel and Aspirin for the Treatment of Polycythemia Vera
A Phase 2 study testing Clopidogrel (Plavix) and Aspirin in people with Polycythemia Vera, run by Ronald Hoffman.
Trial summary
Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the formation of a blood clot in a blood vessel. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Clopidogrel (Plavix) and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jan 2011
- Phase
- Phase 2
- 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 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are included in the study if all of the following criteria are met:
- A documented diagnosis of polycythemia vera established within 5 years of registration. There must be documentation that the patient has met the revised WHO criteria for the diagnosis of polycythemia vera. Patients must meet the 2 major criteria and 1 of the minor criteria. To verify that the criteria have been met, the appropriate laboratory or pathology reports must be submitted demonstrating that the patient has documentation of these diagnostic criteria.
- Major Criteria:
- Hemoglobin >18.5 g/dl in men, >16.5 g/dl in women or other evidence of increased red cell volume.
- Presence of JAK2V617F or other functionally similar mutation such as JAK2 exon 12 mutation
- Minor Criteria:
Show all 39Show fewer
- Bone marrow biopsy showing hypercellularity for age with trilineage growth (panmyelosis) with prominent erythroid, granulocyte, and megakaryocytic proliferation.
- Serum erythropoietin level below the reference range for normal.
- Endogenous erythroid colony formation in vitro.
- High cardiovascular risk due to having experienced a prior vascular event such as an ischemic stroke, myocardial infarction or venous thromboembolism. Objective documentation of these events must be accurately reviewed and registered. Stroke and pulmonary embolism must be documented by an imaging study, deep vein thrombosis by ultrasound or other objective methods, myocardial infarction by typical ECG changes and/or an increase in serum troponin. Minor thrombotic events such as transient ischemic attacks, superficial thrombophlepitis or atypical microcirculatory disturbances alone or in combination are considered to qualifying events.
- No contraindication to aspirin use such as allergy, a history of a previous hemorrhagic stroke or a major gastrointestinal bleed in the previous three months.
- Use of hydroxyurea as a cytoreductive agent.
- Signed informed consent: Patients must have signed consents for both the ISCLAP protocol and for the mandatory correlative biomarker MPD-RC 107 protocol in order to be eligible.
- Serum bilirubin levels less and or equal to 2 times the upper limit of the normal range for the laboratory (ULN).
- Serum glutamic-pyruvic transaminase (SGPT) alanine aminotransferase [ALT]) levels and serum aspartate aminotransferase (AST) less and or equal 2 x ULN.
- Serum creatinine levels less and or equal 1.5 x ULN.
- Women of childbearing potential must have a negative serum or urine pregnancy test prior to clopidogrel treatment and should be advised to avoid becoming pregnant. Women of childbearing potential must practice effective methods of contraception (those generally accepted as standard of care measures). Women of child bearing potential are women who have not been menopausal for 12 months or who have not undergone previous surgical sterilization. If the subject is a woman of childbearing potential, she must use a medically acceptable form of contraception during the study period and for 30 days thereafter.
- Age greater than or euql to 18 years to 81 years of age. Exclusion Criteria
- Subjects are excluded from participating in this study if 1 or more of the following criteria are met:
- Therapy with clopidogrel within the last 12 months.
- Any history of prior treatment with aspirin which has resulted in a significant clinical adverse event requiring the discontinuation of aspirin therapy (e.g. bleeding, GI intolerance, etc. or intolerance to aspirin.
- Patients requiring anticoagulation treatment with warfarin, heparin or low molecular weight heparin for any medical condition.
- Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her physician immediately.
- History of a major bleeding event (requiring blood transfusion or hospitalization, bleeding at a critical site, or life-threatening).
- Clinical indication for the use of clopidogrel and/or a different antithrombotic regimen.
- History of active substance or alcoholic abuse within the last year.
- Known hypersensitivity or contraindication to study treatments.
- Chronic viral hepatitis or chronic liver disease from any other cause associated with a MELD score equal to or higher than 8.
- Presence of any disease (e.g. cancer) that is likely to significantly shorten life expectancy.
- > 81 years of age
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- A history of gastrointestinal bleeding in the last 12 months.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days, or anticipation of the need for major surgical procedure during the course of the study.
- Biopsy or other minor surgical procedure, excluding placement of a vascular access device or bone marrow biopsy, within 7 days prior to study enrollment.
- Ongoing serious, non-healing wound, ulcer, or bone fracture.
- Treatment with a CYP3A4 inhibitor, including azole antifungals (topicals are permitted); protease inhibitors; nefazodone; cyclosporine; erythromycin; clarithromycin; and troleandomycin.
- Serum AST greater than or equal to 2 x ULN Serum ALT greater than or equal 2 x ULN Total Bilirubin greater than or equal 2 X ULN Serum creatinine greater than or equal 1.5 X ULN
- Patients with a diagnosis of polycythemia vera > 5 years from the time of registration
- Patients who do not have high risk polycythemia vera as defined by experiencing a thrombotic event (see section 3.1) occurring since the initial diagnosis of PV.
Who cannot join
None listed.
About this study
Official title: MPD-RC 108: Phase II, Randomized, Double-Blind, Placebo Controlled International Study of Clopidogrel and Aspirin for the Treatment of Polycythemia Vera
Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the formation of a blood clot in a blood vessel. Patients with polycythemia vera are routinely treated with aspirin which has been shown to be effective in reducing their thrombotic risk. However, in polycythemia vera patients with previous thrombosis, a further benefit might be obtained by using the combination of aspirin and clopidogrel which is routinely used in patients with recent acute myocardial ischemia (reduced blood supply to the heart muscle). The study will assess whether this combination therapy greatly increases the risk of bleeding versus aspirin alone, if clopidogrel reduces biological factors that might lead to a stroke or heart attack, and whether a high number of patients with polycythemia vera are resistant to clopidogrel.
Approximately 200 subjects will be enrolled to the Myeloproliferative Disorders-Research Consortium (MPD-RC) study in Europe and the United States with participation expected to last for 7 months (6 months of receiving study medication plus a 30 day follow-up visit).
- Conditions
- Polycythemia Vera
- Being tested
- Clopidogrel (Plavix), Placebo, Aspirin
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel (Plavix)Drug
Also called Plavix
Clopidogrel, aspirin plus hydroxyurea 75mg qd (Plavix) + 81 - 100 mg qd (aspirin) + hydroxyurea
PlaceboDrug
Placebo, aspirin (81-100 mg qd) plus hydroxyurea
AspirinDrug
81-100 mg qd
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Subjects will be randomized to clopidogrel (oral-75 mg per day) in addition to low dose aspirin and hydroxyurea Receives: Drug: Clopidogrel (Plavix); Drug: Aspirin |
| Placebo | Placebo comparator | Subjects will be randomized placebo in addition to low dose aspirin and hydroxyurea Receives: Drug: Placebo; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of using Clopidogrel plus aspirin on Polycythemia Vera patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Could not get drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald Hoffman
- Sponsor type
- University, hospital or other
- Collaborators
- Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Ronald Hoffman, Icahn School of Medicine at Mount Sinai
- Investigators
- Ronald Hoffman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940784
- Sponsor's protocol ID
- GCO 07-0548-00108
- Other IDs
- P01CA108671-01A2, MPD-RC 108
- Acronym
- ISCLAP
- Status last verified
- Nov 2014
- First submitted
- 14 Jul 2009
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MPD-RC 108: Phase II, Randomized, Double-Blind, Placebo Controlled International Study of Clopidogrel and Aspirin for the Treatment of Polycythemia Vera
- ClinicalTrials.gov ID
- NCT00940784
- Acronym / sponsor ID
- ISCLAP / GCO 07-0548-00108
- Conditions
- Polycythemia Vera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not get drug
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ronald HoffmanUniversity, hospital or other
- Collaborators
- Myeloproliferative Disorders-Research Consortium, National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Jul 2009 (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.
Clopidogrel (Plavix) and aspirin are two antithrombotic agents (blood thinners) commonly used in patients with previous thrombotic events (stroke or heart attack). Thrombosis is the formation of a blood clot in a blood vessel. Patients with polycythemia vera are routinely treated with aspirin which has been shown to be effective in reducing their thrombotic risk. However, in polycythemia vera patients with previous thrombosis, a further benefit might be obtained by using the combination of aspirin and clopidogrel which is routinely used in patients with recent acute myocardial ischemia (reduced blood supply to the heart muscle). The study will assess whether this combination therapy greatly increases the risk of bleeding versus aspirin alone, if clopidogrel reduces biological factors that might lead to a stroke or heart attack, and whether a high number of patients with polycythemia vera are resistant to clopidogrel.
Approximately 200 subjects will be enrolled to the Myeloproliferative Disorders-Research Consortium (MPD-RC) study in Europe and the United States with participation expected to last for 7 months (6 months of receiving study medication plus a 30 day follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: Clopidogrel (Plavix), Drug: AspirinSubjects will be randomized to clopidogrel (oral-75 mg per day) in addition to low dose aspirin and hydroxyurea |
| Placebo | Placebo comparator | Drug: Placebo, Drug: AspirinSubjects will be randomized placebo in addition to low dose aspirin and hydroxyurea |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- A documented diagnosis of polycythemia vera established within 5 years of registration. There must be documentation that the patient has met the revised WHO criteria for the diagnosis of polycythemia vera. Patients must meet the 2 major criteria and 1 of the minor criteria. To verify that the criteria have been met, the appropriate laboratory or pathology reports must be submitted demonstrating that the patient has documentation of these diagnostic criteria.
- High cardiovascular risk due to having experienced a prior vascular event such as an ischemic stroke, myocardial infarction or venous thromboembolism. Objective documentation of these events must be accurately reviewed and registered. Stroke and pulmonary embolism must be documented by an imaging study, deep vein thrombosis by ultrasound or other objective methods, myocardial infarction by typical ECG changes and/or an increase in serum troponin. Minor thrombotic events such as transient ischemic attacks, superficial thrombophlepitis or atypical microcirculatory disturbances alone or in combination are considered to qualifying events.
- No contraindication to aspirin use such as allergy, a history of a previous hemorrhagic stroke or a major gastrointestinal bleed in the previous three months.
- Use of hydroxyurea as a cytoreductive agent.
- Signed informed consent: Patients must have signed consents for both the ISCLAP protocol and for the mandatory correlative biomarker MPD-RC 107 protocol in order to be eligible.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clopidogrel (Plavix)Also: PlavixClopidogrel, aspirin plus hydroxyurea 75mg qd (Plavix) + 81 - 100 mg qd (aspirin) + hydroxyurea | Drug | Clopidogrel |
| PlaceboPlacebo, aspirin (81-100 mg qd) plus hydroxyurea | Drug | Placebo |
| Aspirin81-100 mg qd | Drug | Clopidogrel, Placebo |
Primary outcome
To determine the safety and efficacy of using Clopidogrel plus aspirin on Polycythemia Vera patients
Time frame: 2 years
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 26 Nov 2014.
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A Study of Ropeg-Interferon in People With Polycythemia Vera
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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.
Ronald Hoffman, MD principal investigator
Icahn School of Medicine at Mount Sinai
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clopidogrel (Plavix) and Aspirin in people with Polycythemia Vera, run by Ronald Hoffman.
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 39 inclusion and 0 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 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the safety and efficacy of using Clopidogrel plus aspirin on Polycythemia Vera patients (time frame: 2 years). 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 26 Nov 2014.