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

NCT02433587 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 08-14-29
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Endovascular Procedures

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiovascular Event Rates

  Stroke, Myocardial Infarction, Cardiovascular Death

  12 months post-intervention

• Major Adverse Limb Event Rates

  Severe limb ischemia leading to a reintervention or major vascular amputation

  12 months post-intervention

Secondary Outcomes (1)

• Quality of Life Outcome

  12 Months post-intervention

Study Arms (2)

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.

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.

Drug: Aspirin; Drug: Clopidogrel

Interventions

Aspirin DRUG

Patients will take Aspirin 81 mg

Also known as: Acetylsalicylic acid (ASA)

Long Term; Short Term

Clopidogrel DRUG

Patients will take Clopidogrel 75 mg

Also known as: Plavix

Long Term; Short Term

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Vascular Surgery & Endovascular Therapy

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 5, 2015
• Study Start: October 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2023
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

US (1)