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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2004

Interventions

  • Drug: MCI-9042
  • Drug: Aspirin

Arms, Groups and Cohorts

  • Experimental: MCI-9042
  • Active Comparator: Aspirin

Clinical Trial Outcome Measures

Primary Measures

  • recurrence of cerebral infarction

Secondary Measures

  • intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mitsubishi Tanabe Pharma Corporation
  • Provider of Information About this Clinical Study
    • General Manager, Clinical Research Department I, Mitsubishi Tanabe Pharma Corporation
  • Overall Official(s)
    • Yukito Shinohara, MD, Study Chair, Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Citations Reporting on Results

Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.

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