Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Sarpogrelate (MCI-9042)Drug
    Intervention Desc: Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases serotonin levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    ARM 1: Kind: Experimental
    Label: Aspirin
  • MCI-9042 Drug
    ARM 1: Kind: Experimental
    Label: MCI-9042

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients were randomly assigned to receive either sarpogrelate (100 mg three times daily) or aspirin (81 mg once daily).

Outcomes

Type Measure Time Frame Safety Issue
Secondary Safety related events.
Primary recurrence of cerebral infarction No
Secondary intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death

Sponsors