StrokePhase 4COMPRESSNCT00814268

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

A Phase 4 study testing Clopidogrel and Aspirin in people with Stroke, run by Sanofi at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 . Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Stroke
What is being tested?: Clopidogrel and Aspirin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 358 participants
Where: 1 siteSouth Korea
Study dates: Dec 2008to May 2012
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 16Show fewer

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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Sanofi-Aventis Administrative Office
Seoul

Other trials in South Korea

About this study

Official title: COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial

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
Being tested: Clopidogrel, Clopidogrel placebo, Aspirin
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Plavix®
75mg tablet, oral administration once daily
Clopidogrel placeboDrug
Matching tablet, oral administration once daily
AspirinDrug
100mg tablet, oral administration once daily

Study groups in NCT00814268
Study group	Role	What they receive
Combination therapy	Experimental	Administration of Aspirin + Clopidogrel for 30 days Receives: Drug: Clopidogrel; Drug: Aspirin
Monotherapy	Active comparator	Administration of Aspirin + Clopidogrel placebo for 30 days Receives: Drug: Clopidogrel placebo; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke
Measured: Within 30 days following the onset of acute atherothrombotic stroke

Secondary outcomes (5)

Distribution of Modified Rankin Scale (mRS) scores
Measured: 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)
Measured: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with stroke (all kinds)
Measured: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with bleeding episode (major or minor)
Measured: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with symptomatic intracerebral hemorrhage (ICH)
Measured: Within 30 days following the onset of acute atherothrombotic stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008May 2012

First posted24 Dec 2008 (estimated)
Study startDec 2008
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 358 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00814268
Sponsor's protocol ID: CLOPI_L_02452
Acronym: COMPRESS
Status last verified: Feb 2014
First submitted: 23 Dec 2008
Last updated: 28 Feb 2014
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 27418597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: COMbination of Clopidogrel and Aspirin for Prevention of REcurrence in Acute Atherothrombotic Stroke Study: Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial
ClinicalTrials.gov ID: NCT00814268
Acronym / sponsor ID: COMPRESS / CLOPI_L_02452
Conditions: Stroke
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 358 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Dec 2008
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 24 Dec 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Combination therapy	Experimental	Drug: Clopidogrel, Drug: AspirinAdministration of Aspirin + Clopidogrel for 30 days
Monotherapy	Active comparator	Drug: Clopidogrel placebo, Drug: AspirinAdministration of Aspirin + Clopidogrel placebo for 30 days

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClopidogrelAlso: Plavix®75mg tablet, oral administration once daily	Drug	Combination therapy
Clopidogrel placeboMatching tablet, oral administration once daily	Drug	Monotherapy
Aspirin100mg tablet, oral administration once daily	Drug	Combination therapy, Monotherapy

Primary outcome

Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke
Time frame: Within 30 days following the onset of acute atherothrombotic stroke

5 secondary outcomes

Distribution of Modified Rankin Scale (mRS) scores
Time frame: 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)
Time frame: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with stroke (all kinds)
Time frame: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with bleeding episode (major or minor)
Time frame: Within 30 days following the onset of acute atherothrombotic stroke
Number of participants with symptomatic intracerebral hemorrhage (ICH)
Time frame: Within 30 days following the onset of acute atherothrombotic stroke

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
Derived from this study: PubMed 27418597Hong 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.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyang Rim Kim study director

Sanofi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and Aspirin in people with Stroke, run by Sanofi at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with new ischemic lesions after the onset of acute atherothrombotic stroke (time frame: Within 30 days following the onset of acute atherothrombotic stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.