Peripheral Arterial DiseasePhase 3CILO-PERNCT02770274
Cilostazol Following Peripheral Endovascular Procedures
A Phase 3 study testing Cilostazol and Aspirin in people with Peripheral Arterial Disease, run by Attikon Hospital at 2 sites in Greece.
Trial summary
To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Cilostazol and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- Dec 2016to Dec 2021
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled infrainguinal (femoropopliteal or infrapopliteal or both) angioplasty and/or stenting.
- Surgical or endovascular treatment of Inflow iliac artery significant stenosis if deemed necessary.
- Symptomatic severe intermittent claudication (Rutherford-Becker 3) or critical limb ischemia (Rutherford-Becker 4-6).
- Informed consent signed
Who cannot join
- Any contraindication to aspirin or cilostazol intake
- No pedal arch outflow
- Sole iliac artery treatment
- Standard contraindications to angioplasty
- Acute or sub-acute limb ischemia
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
Attikon university General Hospital
Athens, Attica, 15343
Stavros Spiliopoulos, MD, PhD, +30210581 ext. 1832, stavspiliop@med.uoa.gr
Lazaros Reppas, MD, +3021058 ext. 1844, l.reppas@yahoo.com
- Recruiting
Patras Universityu Hospital
Pátrai, Achaia
Dimitris Karnabatidis, MD, PhD, +302613603 ext. 219, karnaby@med.upatras.gr
Panagiotis Kitrou, MD, PhD, +302613603 ext. 218, panoskitrou@gmail.com
About this study
Official title: Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures
To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.
Read the detailed description
This is a multi-center, randomized, single-blinded, phase III, controlled trial investigating the safety and effectiveness of dual antiplatelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral, infrainguinal angioplasty or stenting or both for the management of peripheral arterial disease (intermittent claudication or critical limb ischemia). The study will include in total 200 patients randomized on a 1:1 basis to receive either dual antiplatelet therapy for 6 months cilostazol 100 mg once daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily for 12 months. The study's primary endpoint will be the composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, major amputation, target limb open surgical or endovascular revascularization). Additional therapy with clopidogrel 75mg daily will be added in either group for one month in case of stent placement. Secondary endpoints will include quality of life assessment using dedicated questionnaires, drug- and procedure-related complication rates, target-limb revascularization rates, clinical improvement (ABI and Rutherford-Becker classification changes). Clinical follow up will be performed at 1, 6 and 12 months and will include physical examination, ABI measurements, Rutherford-Becker classification. Maximum follow up period will be 2 years after the index procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Cilostazol, 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.
CilostazolDrug
Dual therapy with Cilostazol 100 mg twice daily
AspirinDrug
Monotherapy with aspirin 100 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Group Cilostazol | Experimental | Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months. Receives: Drug: Cilostazol; Drug: Aspirin |
| Group Aspirin | Active comparator | Patients receiving monotherapy with aspirin 100mg once daily for 12 months. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of major adverse cardiovascular and limb events
Measured: 1 year
Secondary outcomes (7)
Drug-related complications
Major and minor drug-related complications (including bleeding).
Measured: 1 year
Clinical improvement
Clinical improvement of target limb according to Rutherford-Becker classification
Measured: 1-year
Quality of life assessment
Assessment of quality of life changes during follow up period using dedicated questionnaire
Measured: 1 year
Procedure-related complications
Minor and major procedure-related complications
Measured: 1 month
Ankle-Brachial Index (ABI) changes
Ankle-Brachial Index (ABI) measurements during follow up
Measured: 6 and 12 months
Blood cholesterol level monitoring
Blood test to monitor cholesterol levels during follow up
Measured: 6 and 12 months
Blood glucose level monitoring
Blood test to monitor glucose levels during follow up
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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.
- 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
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Patras
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
- Investigators
- Elias Brountzos, MD, PhD, EBIR, Study chair, 2nd Department of Radiology, Interventional Radiology Unit, National and Kapodestrian University of Athens, Attikon University General Hospital, Athens, Greece.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770274
- Sponsor's protocol ID
- 1316/15-2-16
- Acronym
- CILO-PER
- Status last verified
- Jan 2021
- First submitted
- 10 May 2016
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized Trial Comparing Dual Antiplatelet Therapy With CILOstazol Plus Aspirin Versus Aspirin Alone Following PERipheral Endovascular Procedures
- ClinicalTrials.gov ID
- NCT02770274
- Acronym / sponsor ID
- CILO-PER / 1316/15-2-16
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- University Hospital of Patras
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 May 2016 (estimated)
- 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.
To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.
Detailed description
This is a multi-center, randomized, single-blinded, phase III, controlled trial investigating the safety and effectiveness of dual antiplatelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral, infrainguinal angioplasty or stenting or both for the management of peripheral arterial disease (intermittent claudication or critical limb ischemia). The study will include in total 200 patients randomized on a 1:1 basis to receive either dual antiplatelet therapy for 6 months cilostazol 100 mg once daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily for 12 months. The study's primary endpoint will be the composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, major amputation, target limb open surgical or endovascular revascularization). Additional therapy with clopidogrel 75mg daily will be added in either group for one month in case of stent placement. Secondary endpoints will include quality of life assessment using dedicated questionnaires, drug- and procedure-related complication rates, target-limb revascularization rates, clinical improvement (ABI and Rutherford-Becker classification changes). Clinical follow up will be performed at 1, 6 and 12 months and will include physical examination, ABI measurements, Rutherford-Becker classification. Maximum follow up period will be 2 years after the index procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Cilostazol | Experimental | Drug: Cilostazol, Drug: AspirinPatients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months. |
| Group Aspirin | Active comparator | Drug: AspirinPatients receiving monotherapy with aspirin 100mg once daily for 12 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled infrainguinal (femoropopliteal or infrapopliteal or both) angioplasty and/or stenting.
- Surgical or endovascular treatment of Inflow iliac artery significant stenosis if deemed necessary.
- Symptomatic severe intermittent claudication (Rutherford-Becker 3) or critical limb ischemia (Rutherford-Becker 4-6).
- Informed consent signed
Key exclusion criteria (5 listed)
- Any contraindication to aspirin or cilostazol intake
- No pedal arch outflow
- Sole iliac artery treatment
- Standard contraindications to angioplasty
- Acute or sub-acute limb ischemia
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 |
|---|---|---|
| CilostazolDual therapy with Cilostazol 100 mg twice daily | Drug | Group Cilostazol |
| AspirinMonotherapy with aspirin 100 mg once daily | Drug | Group Aspirin, Group Cilostazol |
Primary outcome
Composite endpoint of major adverse cardiovascular and limb events
Time frame: 1 year
7 secondary outcomes
Drug-related complications
Time frame: 1 year
Clinical improvement
Time frame: 1-year
Quality of life assessment
Time frame: 1 year
Procedure-related complications
Time frame: 1 month
Ankle-Brachial Index (ABI) changes
Time frame: 6 and 12 months
Blood cholesterol level monitoring
Time frame: 6 and 12 months
Blood glucose level monitoring
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Peripheral Arterial Disease
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.
Elias Brountzos, MD, PhD, EBIR study chair
2nd Department of Radiology, Interventional Radiology Unit, National and Kapodestrian University of Athens, Attikon University General Hospital, Athens, Greece.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cilostazol and Aspirin in people with Peripheral Arterial Disease, run by Attikon Hospital at 2 sites in Greece.
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 4 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Stavros Spiliopoulos, MD, PhD, EBIR (+306937403468, stavspiliop@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of major adverse cardiovascular and limb events (time frame: 1 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 12 Jan 2021.