Combined Anticoagulation and Antithrombotic TherapyEarly Phase 1NCT04994223
Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
A Early Phase 1 study testing Rivaroxaban 10 MG Oral Tablet [Xarelto] in people with Combined Anticoagulation and Antithrombotic Therapy and PAD - Peripheral Arterial Disease, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 1 site in Pakistan.
Trial summary
EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Combined Anticoagulation and Antithrombotic Therapy, PAD - Peripheral Arterial Disease
- What is being tested?
- Rivaroxaban 10 MG Oral Tablet [Xarelto]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2021to 30 Dec 2022
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients with PAD candidates for revascularization procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Combined Military Hospital
Rawalpindi, Punjab Province, 46000
muhammad jamil, MBBS, FCPS General Surgery, +923216409020
muhammad irfan, MBBS,FCPS Surgery, +923339259643, irfan1373@yahoo.com
About this study
EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.
Read the detailed description
Anticoagulation and antithrombotic therapy is a crucial part of PAD management as it prolongs the patecy of grafts in open surgical revascularization procedures so its proper dosage and duration without increasing risks to the patient and maximizing the benefits is very important.
Currently literature in Pakistan regarding this problem couldn't be found so this study would help assessing the outcomes of anticoagulation and antithrombotic therapy in this population with respect to treatment options available and presentation variability of the peripheral arterial disease. Patients with PAD would be enrolled for 6 months and would be followed upto 12 months and then upto 24 months.
Eligible subjects will be randomized 1:1 to receive either rivaroxaban 5 mg twice daily plus aspirin 75 mg once daily or rivaroxaban-matching placebo twice daily plus aspirin 75 mg once daily stratified by type of procedure; the treatment assignment will be double-blinded. Randomization and study treatment will begin as soon as possible but no later than 10 days after a successfull lower extremity revascularization.
Patients will be prohibited from taking any additional antithrombotic therapy other drugs, including anticoagulants, doses of aspirin >100 mg daily, vorapaxar, ticagrelor, prasugrel, or cilostazol. Enrolled subjects will be having symptomatic PAD defined by evidence of an abnormal ankle-brachial index ≤0.80 in either limb with an anatomy of occlusive disease of involving segments. Subjects would be randomized who had undergone a technically successful endovascular, hybrid, or surgical LER within 10 days and had achieved adequate hemostasis before randomization.
- Being tested
- Rivaroxaban 10 MG Oral Tablet [Xarelto]
- Keywords
- rivaroxaban in PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MG Oral Tablet [Xarelto]Drug
rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
| Study group | Role | What they receive |
|---|---|---|
| Group A(combined anticoagulation plus antithrombotic therapy group) | Experimental | group A patients would be receiving rivaroxaban and aspirin as experimental group to see the efficacy of rivaroxaban in peripheral arterial disease. Receives: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto] |
| Group B( antithrombotic therapy alone group) | Active comparator | group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease. Receives: Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto] |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALI
acute limb ischemia
Measured: upto 1 year
major amputation for vascular reasons
any type of major amputation after revascularivation for PAD
Measured: upto 1 year
MI
myocardial infarction
Measured: upto 1 year
ischemic stroke
ischemic stroke
Measured: upto 1 year
cardiovascular death
death because of cardiovascular events
Measured: upto 1 year
Secondary outcomes (1)
thrombolysis in myocardial infarction(TIMI)major bleeding
combined therapy effect may result in increased bleeding tendency
Measured: 2, 30, 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start2 Jul 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Anticoagulation and Antithrombotic TherapyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients enrolled in the study would be taken informed consent and divided in two groups, group A receiving rivaroxaban plus aspirin and Group B receiving placebo plus aspirin
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Masood, Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994223
- Sponsor's protocol ID
- PAD
- Status last verified
- Apr 2022
- First submitted
- 30 Jul 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: title
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT04994223
- Acronym / sponsor ID
- PAD
- Keywords
- rivaroxaban in PAD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Armed Forces Post Graduate Medical Institute (AFPGMI), RawalpindiUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
EFFECTIVENESS OF COMBINED ANTICOAGULATION AND ANTITHROMBOTIC THERAPY VS ANTITHROMBOTIC THERAPY ALONE AFTER LOWER EXTREMITY REVASCULARIZATION FOR PERIPHERAL ARTERIAL DISEASE.
Detailed description
Anticoagulation and antithrombotic therapy is a crucial part of PAD management as it prolongs the patecy of grafts in open surgical revascularization procedures so its proper dosage and duration without increasing risks to the patient and maximizing the benefits is very important.
Currently literature in Pakistan regarding this problem couldn't be found so this study would help assessing the outcomes of anticoagulation and antithrombotic therapy in this population with respect to treatment options available and presentation variability of the peripheral arterial disease. Patients with PAD would be enrolled for 6 months and would be followed upto 12 months and then upto 24 months.
Eligible subjects will be randomized 1:1 to receive either rivaroxaban 5 mg twice daily plus aspirin 75 mg once daily or rivaroxaban-matching placebo twice daily plus aspirin 75 mg once daily stratified by type of procedure; the treatment assignment will be double-blinded. Randomization and study treatment will begin as soon as possible but no later than 10 days after a successfull lower extremity revascularization.
Patients will be prohibited from taking any additional antithrombotic therapy other drugs, including anticoagulants, doses of aspirin >100 mg daily, vorapaxar, ticagrelor, prasugrel, or cilostazol. Enrolled subjects will be having symptomatic PAD defined by evidence of an abnormal ankle-brachial index ≤0.80 in either limb with an anatomy of occlusive disease of involving segments. Subjects would be randomized who had undergone a technically successful endovascular, hybrid, or surgical LER within 10 days and had achieved adequate hemostasis before randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- patients enrolled in the study would be taken informed consent and divided in two groups, group A receiving rivaroxaban plus aspirin and Group B receiving placebo plus aspirin
| Arm | Type | Receives |
|---|---|---|
| Group A(combined anticoagulation plus antithrombotic therapy group) | Experimental | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]group 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 comparator | Drug: Rivaroxaban 10 MG Oral Tablet [Xarelto]group B patients would be those receiving traditional antithrombotic therapy as usually given n Peripheral Arterial Disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with PAD candidates for revascularization procedures
Key exclusion criteria (5 listed)
- 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
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 10 MG Oral Tablet [Xarelto]rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival | Drug | Group A(combined anticoagulation plus antithrombotic therapy group), Group B( antithrombotic therapy alone group) |
Primary outcome
ALI
Time frame: upto 1 year
acute limb ischemia
major amputation for vascular reasons
Time frame: upto 1 year
any type of major amputation after revascularivation for PAD
MI
Time frame: upto 1 year
myocardial infarction
ischemic stroke
Time frame: upto 1 year
ischemic stroke
cardiovascular death
Time frame: upto 1 year
death because of cardiovascular events
1 secondary outcome
thrombolysis in myocardial infarction(TIMI)major bleeding
Time frame: 2, 30, 180 and 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: Yes. title
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rivaroxaban 10 MG Oral Tablet [Xarelto] in people with Combined Anticoagulation and Antithrombotic Therapy and PAD - Peripheral Arterial Disease, run by Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi at 1 site in Pakistan.
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 1 inclusion and 5 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 3 May 2022. 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 Pakistan. 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?
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 Ayesha masood, MBBS, FCPS Surgery (+923059159699, laparoscopy.6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALI (time frame: upto 1 year). The study lists 5 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 3 May 2022.