Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01995370 : Cilostazol Stroke Prevention Study for Antiplatelet Combination
PhasePhase 3
AgesMin: 20 Years Max: 85 Years
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01995370      |      Link to official Clinicaltrials.gov listing
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