Cilostazol Following Peripheral Endovascular Procedures
Paraules clau
Resum
Descripció
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.
Dates
Darrera verificació: | 06/30/2019 |
Primer enviat: | 05/09/2016 |
Inscripció estimada enviada: | 05/10/2016 |
Publicat per primera vegada: | 05/11/2016 |
Última actualització enviada: | 07/01/2019 |
Publicació de l'última actualització: | 07/04/2019 |
Data d'inici de l'estudi real: | 11/30/2016 |
Data estimada de finalització primària: | 11/30/2020 |
Data estimada de finalització de l’estudi: | 11/30/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Group Cilostazol
Drug: Aspirin
Fase
Grups de braços
Braç | Intervenció / tractament |
---|---|
Experimental: Group Cilostazol Patients receiving dual antiplatelet therapy with cilostazol 100mg twice daily and aspirin 100mg once daily for 12 months. | Drug: Group Cilostazol Dual therapy with Cilostazol 100 mg twice daily |
Active Comparator: Group Aspirin Patients receiving monotherapy with aspirin 100mg once daily for 12 months. |
Criteris d'elegibilitat
Edats elegibles per estudiar | 18 Years Per a 18 Years |
Sexes elegibles per estudiar | All |
Accepta voluntaris saludables | Sí |
Criteris | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Resultat
Mesures de resultats primaris
1. Composite endpoint of major adverse cardiovascular and limb events [1 year]
Mesures de resultats secundaris
1. Drug-related complications [1 year]
2. Clinical improvement [1-year]
3. Quality of life assessment [1 year]
4. Procedure-related complications [1 month]
5. Ankle-Brachial Index (ABI) changes [6 and 12 months]
6. Blood cholesterol level monitoring [6 and 12 months]
7. Blood glucose level monitoring [6-12 months]