Post-marketing Study of Cilostazol (Cilostazol Stroke Prevention Study 2)

JRCT ID: jRCT1080220034

Registered date:06/09/2005

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Cerebral infarction (excluding cardiogenic cerebral embolism)
• Date of first enrollment: 10/12/2003
• Target sample size: 2600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : Cilostazol
INN of investigational material : Cilostazol
Therapeutic category code : 339 Other agents relating to blood and body fluides
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : Aspirin
INN of investigational material : Aspirin
Therapeutic category code : 339 Other agents relating to blood and body fluides
Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome

efficacy
Number of patients with first occurence of stroke

Secondary Outcome

efficacy
- Recurrence of cerebral infarction during the treatment period (and up until 10 days after treatment completion)
- Occurrence of ischaemic cerebrovascular disorders (cerebral infarction or TIA) during the treatment period (and up until 10 days after treatment completion)
- All-cause deaths during the treatment period (and up until 38 days after treatment completion)
- Recurrence of stroke (cerebral infarction, cerebral haemorrhage, or subarachnoid haemorrhage) and occurrence of TIA, angina pectoris, myocardial infarction, cardiac failure, or haemorrhage requiring hospitalization during the treatment period (and up until 10 days after treatment completion)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(1) Patients with stable medical conditions after occurrence of cerebral infarction,
(2) Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI,
(3) Patients aged 20 to 80 years old (inclusive) at time of consent,
(4) Patients with no cardiac diseases that may be associated with cardiogenic cerebral embolism,
(5) Patients without asymptomatic cerebral infarction,
(6) Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction,
(7) Patients without severe disturbances/impairments following occurrence of cerebral infarction

Exclude criteria

(1) Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
(2) Pregnant, possibly pregnant, or nursing women
(3) Patients with ischemic heart failure
(4) Patients with peptic ulcer
(5) Patients with severer blood disorders
(6) Patients with severe hepatic or renal
(7) Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
(8) Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
(9) Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
(10) Patients who are being treated with ticlopidine hydrochloride
(11) Patients who are participating in another study for an investigational drug
(12) Patients who are otherwise judged inappropriate for inclusion in the study by the investigators

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT00234065,JapicCTI-050034