Peripheral Arterial DiseaseEarly Phase 1NCT05308030
Outcomes of Rivaroxaban and Aspirin in PAD After Endovascular Revascularization
A Early Phase 1 study testing Rivaroxaban and Aspirin in people with Peripheral Arterial Disease, run by Assiut University.
Trial summary
Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Rivaroxaban and Aspirin
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to Jul 2023
- Phase
- Early Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 .
- Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease.
- Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization.
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- Subject has provided written informed consent.
Who cannot join
- Subject's age less than 40.
- Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
- Imminent or foreseeable amputation.
- Subject already had a major amputation on the affected extremity
- Subject has emergent ischemic lesion [such as gas forming infection].
- Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre- treatment.
- Subject is not in the position to be primarily revascularized or refuses surgery.
- Acute embolic ischemia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Rivaroxaban and Aspirin in Patients With Lower Extremity Peripheral Arterial Disease After Endovascular Revascularization.
Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization
Read the detailed description
Globally more than 200 million people suffer from peripheral artery disease (PAD), and the incidence is rising due to advancing age, high rates of smoking in certain regions of the world, and the rising incidence of type 2 diabetes.
PAD patients have wide-spread atherosclerosis and suffer a high risk of major cardiovascular (CV) events, with atherothrombosis as the underlying pathophysiologicmechanism. Symptomatic peripheral artery disease (PAD) is associated with a reduction in exercise capacity and quality of life and risk for tissue loss that is often treated with lower extremity revascularization (LER) to relieve symptoms and to prevent limb loss in a large portion of the population.
PAD is also associated with a heightened risk for major adverse cardiovascular and limb events.
LER is associated with a substantial increased risk of ischemic cardiovascular and limb events, including a 4-fold increased risk for acute limb ischemia (ALI), an ≈30% increased risk of myocardial infarction (MI), and an increased risk of rehospitalization after LER.
Observations from a large administrative database showed that patients with PAD after LER had an early heightened risk for ischemic limb events and a later increased risk for cardiovascular events.
Despite the common use of dual antiplatelet therapy after endovascular LER, this strategy is not supported by any Class 1A PAD guideline recommendations. Guidelines do give Class IIB recommendation for dual antiplatelet therapy for endovascular and surgical procedures (American and European) and Class IIA recommendation with Level of Evidence C for endovascular procedures (European),whereas use of dual antiplatelet therapy is discouraged by the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Recently Antiplatelet therapy with low-dose factor Xa inhibition with rivaroxaban 2.5 mg twice daily used in combination with aspirin have been shown to reduce ischemic cardiovascular and limb events in patients with stable PAD. In patients with PAD undergoing LER, the VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of the combination of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily versus placebo plus aspirin on the composite outcome of ALI, major amputation of a vascular pathogenesis, cardiovascular death, ischemic stroke, or MI, but with a numeric increase in major TIMI (Thrombolysis in Myocardial Infarction) bleeding.
So, Investigators decided to assess the outcomes of using Rivaroxaban 2.5 mg twice daily plus Aspirin 100 mg in patients with lower extremity PAD after endovascular revascularization
- Conditions
- Peripheral Arterial Disease
- Being tested
- Rivaroxaban and Aspirin
- 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.
Rivaroxaban and AspirinDrug
After the endovascular intervention, Anticoagulant therapy plus Antiplatelet therapy will be maintained (Aspirin 100 mg once daily and Rivaroxaban 2.5 mg twice daily) for 3 months, and then Aspirin alone indefinitely
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency
Determination of patency of the target limb is essentially by measuring Ankle brachial Index(ABI)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Aug 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
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 Assiut UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Ahmed Elshimy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308030
- Sponsor's protocol ID
- Rivaroxaban in PAD after ER
- Status last verified
- Jul 2022
- First submitted
- 24 Mar 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Rivaroxaban and Aspirin in Patients With Lower Extremity Peripheral Arterial Disease After Endovascular Revascularization.
- ClinicalTrials.gov ID
- NCT05308030
- Acronym / sponsor ID
- Rivaroxaban in PAD after ER
- Conditions
- Peripheral Arterial Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 1 Apr 2022 (actual)
- 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.
Assessing the outcomes of using Rivaroxaban plus Aspirin in patients with Lower Extremity Peripheral Arterial Disease after Endovascular Revascularization
Detailed description
Globally more than 200 million people suffer from peripheral artery disease (PAD), and the incidence is rising due to advancing age, high rates of smoking in certain regions of the world, and the rising incidence of type 2 diabetes.
PAD patients have wide-spread atherosclerosis and suffer a high risk of major cardiovascular (CV) events, with atherothrombosis as the underlying pathophysiologicmechanism. Symptomatic peripheral artery disease (PAD) is associated with a reduction in exercise capacity and quality of life and risk for tissue loss that is often treated with lower extremity revascularization (LER) to relieve symptoms and to prevent limb loss in a large portion of the population.
PAD is also associated with a heightened risk for major adverse cardiovascular and limb events.
LER is associated with a substantial increased risk of ischemic cardiovascular and limb events, including a 4-fold increased risk for acute limb ischemia (ALI), an ≈30% increased risk of myocardial infarction (MI), and an increased risk of rehospitalization after LER.
Observations from a large administrative database showed that patients with PAD after LER had an early heightened risk for ischemic limb events and a later increased risk for cardiovascular events.
Despite the common use of dual antiplatelet therapy after endovascular LER, this strategy is not supported by any Class 1A PAD guideline recommendations. Guidelines do give Class IIB recommendation for dual antiplatelet therapy for endovascular and surgical procedures (American and European) and Class IIA recommendation with Level of Evidence C for endovascular procedures (European),whereas use of dual antiplatelet therapy is discouraged by the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Recently Antiplatelet therapy with low-dose factor Xa inhibition with rivaroxaban 2.5 mg twice daily used in combination with aspirin have been shown to reduce ischemic cardiovascular and limb events in patients with stable PAD. In patients with PAD undergoing LER, the VOYAGER PAD trial (Vascular Outcomes Study of ASA Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease) demonstrated superiority of the combination of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily versus placebo plus aspirin on the composite outcome of ALI, major amputation of a vascular pathogenesis, cardiovascular death, ischemic stroke, or MI, but with a numeric increase in major TIMI (Thrombolysis in Myocardial Infarction) bleeding.
So, Investigators decided to assess the outcomes of using Rivaroxaban 2.5 mg twice daily plus Aspirin 100 mg in patients with lower extremity PAD after endovascular revascularization
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥40 .
- Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease.
- Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization.
- Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
- Subject has provided written informed consent.
Key exclusion criteria (8 listed)
- Subject's age less than 40.
- Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg.
- Imminent or foreseeable amputation.
- Subject already had a major amputation on the affected extremity
- Subject has emergent ischemic lesion [such as gas forming infection].
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 |
|---|---|---|
| Rivaroxaban and AspirinAfter the endovascular intervention, Anticoagulant therapy plus Antiplatelet therapy will be maintained (Aspirin 100 mg once daily and Rivaroxaban 2.5 mg twice daily) for 3 months, and then Aspirin alone indefinitely | Drug | – |
Primary outcome
Patency
Time frame: One year
Determination of patency of the target limb is essentially by measuring Ankle brachial Index(ABI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rivaroxaban and Aspirin in people with Peripheral Arterial Disease, run by Assiut University.
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 8 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hassan Elshimy (+201032062360, ahmedelshimy186@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency (time frame: One year). 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 20 Jul 2022.