Cilostazol Stroke Prevention Study for Antiplatelet Combination

Phase 4

Completed

• Conditions: Noncardioembolic Cerebral Infarction
• Interventions: Drug: aspirin; Drug: clopidogrel; Drug: cilostazol

• Registration Number: NCT01995370
• Lead Sponsor: Japan Cardiovascular Research Foundation

Brief Summary

To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-15
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-26
• Study Start: 2013-12-13
• Primary Completion: 2018-12-07
• Study Completion: 2018-12-07
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1884

Inclusion Criteria

• Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment

• Patients with a responsible lesion identified by MRI

• Patients aged 20 to 85 years old when providing informed consent

• Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent

• Patients meeting at least one of the following criteria a-c:

  1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)

  2. at least 50% stenosis of an extracranial artery (the common carotid artery，internal carotid artery，vertebral artery，brachiocephalic artery，or subclavian artery)

  3. Two or more of the following risk factors

     • Aged 65 years or more
     • Diabetes mellitus
     • Hypertension
     • Peripheral arterial disease
     • Chronic kidney disease
     • History of IS (excluding the index IS for this study)
     • History of ischemic heart disease
     • Smoking (only current smokers)

• Patients considered to be able to visit the study site for ambulatory care throughout the observation period

• Patients who provided written informed consent

Exclusion Criteria

• Patients with emboligenic heart disease

• Patients taking any anticoagulant agents

• Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker

• Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period

• Patients with a drug-eluting coronary stent implanted within one year

• Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders

• Patients with a history of hypersensitivity to cilostazol

• Patients with congestive heart failure or uncontrolled angina pectoris

• Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)

• Patients with severe liver or renal dysfunction

• Women who are pregnant, breast-feeding, or of child-bearing potential

• Patients with a malignant tumor requiring treatment

• Patients who are taking aspirin, and meet any of the following criteria:

  • History of hypersensitivity to aspirin or salicylic acid analogues
  • Current peptic ulcer
  • Aspirin-induced asthma or its history

• Patients who are taking clopidogrel, and meet the following criterion:

  ・History of hypersensitivity to clopidogrel

• Patients who are participating in any other clinical studies

• Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy group	aspirin	Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
Monotherapy group	clopidogrel	Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
DAPT group	aspirin	Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
DAPT group	clopidogrel	Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
DAPT group	cilostazol	Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Primary Outcome Measures

Name	Time	Method
Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours	every 6 months	An "ischemic stroke" hereafter indicates a symptomatic ischemic stroke.

Secondary Outcome Measures

Name	Time	Method
Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]	every 6 months
IS or transient ischemic attack (TIA)	every 6 months
Adverse events and adverse drug reactions	every 6 months
Severe or life-threatening hemorrhage (GUSTO Criteria)	every 6 months
SAH or ICH	every 6 months
Death from any cause	every 6 months
Stroke (IS，ICH，SAH), myocardial infarction (MI), or vascular death	every 6 months
All vascular events: stroke, MI, and other vascular events	every 6 months

Trial Locations

Locations (1)

Japan Cardiovascular Research Foundation; 🇯🇵 Osaka, Japan