Sarpogrelate is an antiplatelet drug that decreases 5-hydroxytryptamine( 5-HT )levels in platelets via blockade of 5-HT2 receptors, has been used in atherosclerotic peripheral arterial disease.

SACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate ( 100mg tree times daily ) and aspirin ( 81mg once daily ) in 1510 patient with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrent of cerebral infarction; their relative safety was also assessed.

Condition	Intervention	Phase
Cerebral Infarction	Drug: MCI-9042	Phase III

Further Study Details: 

Primary Outcomes: recurrent of cerebral infarction
Secondary Outcomes: intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke,transient ischemic attack, myocardial infarction, unstable angina, or vascular death
Expected Total Enrollment:  1500

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Cerebral infarction except cardiac source of embolism
2. Oncet≧ 1 week ≦ 6 month before randomization
3. Neurological signs persisting≧ 1 day from onset
4. CT or MRI detection of responsible site
5. age≧20
6. Systolic pressure≦180 mmHg, Diastolic pressure≦130 mmHg

Exclusion Criteria:

1)Functional outcome at randomization: Modified Rankin Scale=4, 5 2)Previous or planned for vascular surgery to cerebral infarction 3)History of intracranial hemorrhage 4)History of systemic bleeding, or other history of bleeding diathesis or coagulopathy 5)With severe complications ( renal or hepatic insufficiency, heart failure, hemopathy, and so on ) 6)Pregnant or possibly pregnant women, or nursing mothers 7)History of sarpogrelate and aspirin sensitivity 8)Treating malignant tumor or treated within 5 years 9)Current peptic ulceration

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Study chairs or principal investigators

Yukito Shinohara, MD,  Study Chair,  SACCESS Study Group   

Study ID Numbers:  MCI9042-15
Last Updated:  August 11, 2005
Record first received:  August 11, 2005
ClinicalTrials.gov Identifier:  NCT00129805
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-08-23