COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke

NCT00814268 | Completed Phase 4

• 1 other identifier: CLOPI_L_02452
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective:

• Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion . Secondary objectives:
• Comparison of Modified Rankin scale (mRS) scores;
• Comparison of the Incidence of all kinds of stroke and vascular death;
• Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic intracerebral hemorrhages during the follow-up period.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke

  Within 30 days following the onset of acute atherothrombotic stroke

Secondary Outcomes (5)

• Distribution of Modified Rankin Scale (mRS) scores

  Day 30 after the onset of acute atherothrombotic stroke

• Number of participants with non-fatal stroke, myocardial infarction (MI) or cardiovascular death (composite endpoint, first-ever)

  Within 30 days following the onset of acute atherothrombotic stroke

• Number of participants with stroke (all kinds)

  Within 30 days following the onset of acute atherothrombotic stroke

• Number of participants with bleeding episode (major or minor)

  Within 30 days following the onset of acute atherothrombotic stroke

• Number of participants with symptomatic intracerebral hemorrhage (ICH)

  Within 30 days following the onset of acute atherothrombotic stroke

Study Arms (2)

Combination therapy

EXPERIMENTAL

Administration of Aspirin + Clopidogrel for 30 days

Drug: Clopidogrel; Drug: Aspirin

Monotherapy

ACTIVE COMPARATOR

Administration of Aspirin + Clopidogrel placebo for 30 days

Drug: Clopidogrel placebo; Drug: Aspirin

Interventions

Clopidogrel DRUG

75mg tablet, oral administration once daily

Also known as: Plavix®

Combination therapy

Clopidogrel placebo DRUG

Matching tablet, oral administration once daily

Monotherapy

Aspirin DRUG

100mg tablet, oral administration once daily

Combination therapy; Monotherapy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic stroke diagnosed within 48 hours from symptom onset;
• Cerebral ischemic lesion observed on diffusion-weighted magnetic resonance imaging (DWI MRI);
• Relevant atherothrombotic lesions on magnetic resonance angiography (MRA) or computed tomography angiography (CTA);
• Study drug administration within 48 hours from symptom onset;
• mRS score is 0-2 before the stroke.

You may not qualify if:

• Evidences of other relevant brain lesions such as Intracerebral hemorrhage (ICH) or brain tumor;
• Suspicious of stroke due to small-vessel occlusion;
• Stroke due to cardioembolism;
• Clinical necessity of conventional angiography or intervention before the end of study;
• Past history of ICH;
• Bleeding diathesis or coagulopathy;
• Chronic anemia (Hb\<8.0) or thrombocytopenia (PLT\<100K);
• Chronic liver disease (AST\> 100 or ALT\>100);
• Any other clinically relevant serious disease, including renal failure ( creatinine clearance\<30mL/min);
• Allergy to Aspirin or clopidogrel;
• Subjected to intervention or surgical treatments within 3 months;
• Thrombolysis performed with rt-PA or UK after the stroke;
• Participation in another clinical study within the previous 30 days;
• Suspicious of poor drug compliance and requirements of the protocol;
• Females who are pregnant, breast-feeding, or childbearing potential and not using medically acceptable and effective contraception.

Sponsors & Collaborators

• Sanofi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Related Publications (1)

• Hong KS, Lee SH, Kim EG, Cho KH, Chang DI, Rha JH, Bae HJ, Lee KB, Kim DE, Park JM, Kim HY, Cha JK, Yu KH, Lee YS, Lee SJ, Choi JC, Cho YJ, Kwon SU, Kim GM, Sohn SI, Park KY, Kang DW, Sohn CH, Lee J, Yoon BW; COMPRESS Investigators. Recurrent Ischemic Lesions After Acute Atherothrombotic Stroke: Clopidogrel Plus Aspirin Versus Aspirin Alone. Stroke. 2016 Sep;47(9):2323-30. doi: 10.1161/STROKEAHA.115.012293. Epub 2016 Jul 14.

  PMID: 27418597 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hyang Rim Kim

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

KR (1)