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Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

Primary Purpose

Peripheral Arterial Disease, Endovascular Procedures

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Clopidogrel
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provide signed informed consent before initiation of any study related procedures
  2. Be at least 18 years of age
  3. Successful percutaneous lower extremity (iliac and infrainguinal) endovascular revascularization (percutaneous transluminal angioplasty, and /or stent).
  4. At least 1 vessel run-off in segment distal to the intervention
  5. Rutherford Classification 2-5 that is unresponsive to medical therapy

Exclusion Criteria:

  1. Acute limb ischemia
  2. Procedure includes device deployment that has specific FDA regulations for anticoagulation/anti-platelet medication regimen.
  3. Patient undergoing atherectomy procedure
  4. Intervention includes deployment of drug eluted stent
  5. Critical limb ischemia (Rutherford Classification 6)
  6. Thrombocytopenia: Platelet count <50k
  7. Liver disease (Childs-Pugh B or C)
  8. Existing need for on going clopidogrel therapy
  9. Proton Pump Inhibitor Use (If unable to be switched)
  10. Need for therapeutic anticoagulation
  11. Known hypercoagulable disorder
  12. Allergy or contraindication to aspirin or clopidogrel
  13. Pregnancy
  14. Patients enrolled in another investigational drug or device study within the past 30 days

Sites / Locations

  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short Term

Long Term

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular Event Rates
Stroke, Myocardial Infarction, Cardiovascular Death
Major Adverse Limb Event Rates
Severe limb ischemia leading to a reintervention or major vascular amputation

Secondary Outcome Measures

Quality of Life Outcome
Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey

Full Information

First Posted
April 29, 2015
Last Updated
October 2, 2019
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02433587
Brief Title
Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Official Title
Evaluation of Short Versus Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Never recruited any patients.
Study Start Date
October 2019 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the trial is to evaluate short versus long duration dual antiplatelet therapy in patients undergoing lower extremity endovascular revascularization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Endovascular Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Term
Arm Type
Experimental
Arm Description
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.
Arm Title
Long Term
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid (ASA)
Intervention Description
Patients will take Aspirin 81 mg
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
Patients will take Clopidogrel 75 mg
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Event Rates
Description
Stroke, Myocardial Infarction, Cardiovascular Death
Time Frame
12 months post-intervention
Title
Major Adverse Limb Event Rates
Description
Severe limb ischemia leading to a reintervention or major vascular amputation
Time Frame
12 months post-intervention
Secondary Outcome Measure Information:
Title
Quality of Life Outcome
Description
Assessed by Intermittent Claudication Questionnaire and Short Form-36 Health Survey
Time Frame
12 Months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Short vs Long Duration Dual Antiplatelet Therapy in Patients Undergoing Lower Extremity Endovascular Revascularization

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