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Completed

NCT Number: NCT00129805

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

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.

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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCI-9042

Drug

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

Aspirin

Drug

Primary outcomes

  1. recurrence of cerebral infarction

Secondary outcomes

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

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Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Aug 12, 2005
Registry last updated
Aug 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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