Peripheral Arterial DiseasePhase 3NCT02433587
Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
A Phase 3 study testing Aspirin and Clopidogrel in people with Peripheral Arterial Disease and Endovascular Procedures, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Endovascular Procedures
- What is being tested?
- Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2019to Jul 2023
- 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
- Provide signed informed consent before initiation of any study related procedures
- Be at least 18 years of age
- Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
- At least 1 vessel run-off in segment distal to the intervention
- Rutherford Classification 2-5 that is unresponsive to medical therapy
Who cannot join
- Acute limb ischemia
- Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
- Patient undergoing atherectomy procedure
- Intervention includes deployment of drug eluted stent
- Critical limb ischemia (Rutherford Classification 6)
- Thrombocytopenia: Platelet count <50k
Show all 14Show fewer
- Liver disease (Childs-Pugh B or C)
- Existing need for on going clopidogrel therapy
- Proton Pump Inhibitor Use (If unable to be switched)
- Need for therapeutic anticoagulation
- Known hypercoagulable disorder
- Allergy or contraindication to aspirin or clopidogrel
- Pregnancy
- Patients enrolled in another investigational drug or device study within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
- Being tested
- Aspirin, Clopidogrel
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic acid (ASA)
Patients will take Aspirin 81 mg
ClopidogrelDrug
Also called Plavix
Patients will take Clopidogrel 75 mg
| Study group | Role | What they receive |
|---|---|---|
| Short Term | Experimental | The short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only. Receives: Drug: Aspirin; Drug: Clopidogrel |
| Long Term | Experimental | The long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only. Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Event Rates
Stroke, Myocardial Infarction, Cardiovascular Death
Measured: 12 months post-intervention
Major Adverse Limb Event Rates
Severe limb ischemia leading to a reintervention or major vascular amputation
Measured: 12 months post-intervention
Secondary outcomes (1)
Quality of Life Outcome
Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey
Measured: 12 Months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startOct 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Never recruited any patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikram S. Kashyap, M.D., University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433587
- Sponsor's protocol ID
- 08-14-29
- Status last verified
- Oct 2019
- First submitted
- 29 Apr 2015
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
- ClinicalTrials.gov ID
- NCT02433587
- Acronym / sponsor ID
- 08-14-29
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never recruited any patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 May 2015 (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.
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Term | Experimental | Drug: Aspirin, Drug: ClopidogrelThe short term group will continue Aspirin 81mg and Clopidogrel 75mg for 1 month after the intervention. After that, they will continue Aspirin 81mg only. |
| Long Term | Experimental | Drug: Aspirin, Drug: ClopidogrelThe long term group will continue Aspirin 81mg and Clopidogrel 75mg for 6 months after the intervention. After this time, they will continue on Aspirin 81mg only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide signed informed consent before initiation of any study related procedures
- Be at least 18 years of age
- Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
- At least 1 vessel run-off in segment distal to the intervention
- Rutherford Classification 2-5 that is unresponsive to medical therapy
Key exclusion criteria (14 listed)
- Acute limb ischemia
- Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
- Patient undergoing atherectomy procedure
- Intervention includes deployment of drug eluted stent
- Critical limb ischemia (Rutherford Classification 6)
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic acid (ASA)Patients will take Aspirin 81 mg | Drug | Long Term, Short Term |
| ClopidogrelAlso: PlavixPatients will take Clopidogrel 75 mg | Drug | Long Term, Short Term |
Primary outcome
Major Adverse Cardiovascular Event Rates
Time frame: 12 months post-intervention
Stroke, Myocardial Infarction, Cardiovascular Death
Major Adverse Limb Event Rates
Time frame: 12 months post-intervention
Severe limb ischemia leading to a reintervention or major vascular amputation
1 secondary outcome
Quality of Life Outcome
Time frame: 12 Months post-intervention
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 7 Oct 2019.
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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 Aspirin and Clopidogrel in people with Peripheral Arterial Disease and Endovascular Procedures, run by University Hospitals Cleveland Medical Center 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: withdrawn, as of the sponsor's last update on 7 Oct 2019. 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 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?
Major Adverse Cardiovascular Event Rates (time frame: 12 months post-intervention). The study lists 2 primary outcomes in all. 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 7 Oct 2019.