Trial | NCT00129805  Report issue

Title

Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1510
Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.

S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.
Study Started
Jan 31
2001
Primary Completion
Sep 30
2004
Study Completion
Sep 30
2004
Last Update
Aug 19
2008
Estimate

Drug MCI-9042

  • Other names: Sarpogrelate(INN), ANPLAG(R)

Drug Aspirin

MCI-9042 Experimental

Aspirin Active Comparator

Criteria 

Inclusion Criteria:

Cerebral infarction except cardiac source of embolism
Onset ≧ 1 week to ≦ 6 months before randomization
Neurological signs persisting ≧ 1 day from onset
Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
Age ≧ 20 years
Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg

Exclusion Criteria:

Functional outcome at randomization: Modified Rankin Scale = 4, 5
Previous or planned vascular surgery for cerebral infarction
History of intracranial hemorrhage
History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
Pregnant or possibly pregnant women, or nursing mothers
History of sarpogrelate and aspirin sensitivity
Treating malignant tumor or treated within 5 years
Current peptic ulceration
No Results Posted