Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
1 other identifier
interventional
60
1 country
1
Brief Summary
EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2021
CompletedFirst Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 3, 2022
April 1, 2022
1.5 years
July 30, 2021
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
ALI
acute limb ischemia
upto 1 year
major amputation for vascular reasons
any type of major amputation after revascularivation for PAD
upto 1 year
MI
myocardial infarction
upto 1 year
ischemic stroke
ischemic stroke
upto 1 year
cardiovascular death
death because of cardiovascular events
upto 1 year
Secondary Outcomes (1)
thrombolysis in myocardial infarction(TIMI)major bleeding
2, 30, 180 and 365 days
Study Arms (2)
Group A(combined anticoagulation plus antithrombotic therapy group)
EXPERIMENTALgroup A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease.
Group B( antithrombotic therapy alone group)
ACTIVE COMPARATORgroup B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease.
Interventions
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
Eligibility Criteria
You may qualify if:
- \- all patients with PAD candidates for revascularization procedures
You may not qualify if:
- planned long-term dual antiplatelet therapy (\>6 months),
- clinical requirement for therapeutic anticoagulation,
- recent acute limb ischemia or acute coronary syndrome,
- medical condition that could increase the risk of major bleeding, significantly impaired renal function at baseline (estimated glomerular filtration rate \<15 mL•min-1•1.73 m-2),
- any documented history of intracranial hemorrhage, stroke, or transient ischemic attack
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Combined Military Hospital
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- participants enrolled in the study and the principal investigator would not be knowing the drug regimens used in group A and Group B participants
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Trainee in vascular surgery
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 6, 2021
Study Start
July 2, 2021
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
May 3, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 6 months from start of study
title