Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00386191
Other study ID # SFY6913
Secondary ID SR25990
Status Completed
Phase Phase 4
First received October 10, 2006
Last updated February 23, 2010
Start date September 2006
Est. completion date December 2008

Study information

Verified date February 2010
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The primary objective is to compare the safety of clopidogrel 50mg and 75mg in cerebral infarction with respect to incidence of bleeding adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 1110
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria:

- Patients with an episode of cerebral infarction (excluding cardiogenic cerebral thromboembolism) occurring at least 8 days prior to randomization and for whom the clinical course up to randomization is well-documented

- Patients with a cerebral infarct confirmed by Computed Tomography or Magnetic Resonance Image

- Body weight : > 50 kg

Exclusion Criteria:

- Patients with cardiogenic cerebral thromboembolism or disease that could precipitate cardiogenic cerebral thromboembolism, such as atrial fibrillation or valvular hear disease (including valve replacement)

- Patients with Transient Ischemic Attack occuring after the last episode of cerebral infarction

- Patients with serious impairment that would hinder detection of new ischemic event

- Patients with bleeding diathesis, coagulopathy, or hemorrhagic disease

- Patients with history of intracranial hemorrhage

- Patients with diabetic retinopathy

- Hypertensive patients with a persistent increase of blood pressure.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
clopidogrel (SR25990C)
oral administration

Locations

Country Name City State
Japan Sanofi-Aventis Administrative Office Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of bleeding adverse events study period Yes
Secondary Incidence of Serious Adverse Events, serious bleeding events, adverse events. Incidence of vascular events. study period Yes
See also
  Status Clinical Trial Phase
Withdrawn NCT02551003 - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy Phase 1/Phase 2
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Completed NCT00684515 - Trial to Assess the Safety of Vorapaxar in Japanese Subjects With Cerebral Infarction (P05005; MK-5348-017) Phase 2
Not yet recruiting NCT04082091 - Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Terminated NCT01684462 - The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke Phase 2
Completed NCT00004734 - Vitamin Therapy for Prevention of Stroke Phase 3
Completed NCT02684825 - Detection of Silent Atrial Fibrillation aFter Ischemic StrOke N/A
Completed NCT02248233 - Nimodipine for Treating Acute Massive Cerebral Infarction Phase 4
Completed NCT02963545 - TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke N/A
Completed NCT02511249 - Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke N/A
Completed NCT02101606 - Penumbral Based Novel Thrombolytic Therapy in Acute Ischemic Stroke Phase 2
Completed NCT01500421 - Safty and Feasibility Study of Therapeutic Cooling in Acute Ischemic Stroke (COOLAID Øresund) Phase 2
Completed NCT00829361 - Stroke Telemedicine for Arizona Rural Residents Trial N/A
Recruiting NCT01003470 - Treating Apoplectic Sequela With Acupuncture: a Randomized Controlled Study Phase 2
Terminated NCT00331890 - ICTUS Study: International Citicoline Trial on Acute Stroke Phase 3
Not yet recruiting NCT04696523 - Effect of Xenon on Brain Injury After Aneurysmal Subarachnoid Hemorrhage Phase 2
Completed NCT03741400 - Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke N/A
Recruiting NCT04908241 - Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke (TRAIL-RCT) N/A