Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke (AGREE)

June 11, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial

An open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. Eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). The primary outcome is the proportion of the excellent functional outcome (modified Rankin scale 0-1) at 90 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
472

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 40-80 years.
  2. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness.
  3. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN).
  4. Absence of large vessel occlusion on CTA.
  5. Pre-stroke mRS ≤ 1.
  6. Signed informed consent.

Exclusion Criteria:

  1. Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.
  2. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan.
  3. Acute coronary syndrome suggested by Electrocardiogram.
  4. History of gastrointestinal bleeding.
  5. Planned sequential IVT or endovascular treatment.
  6. History of allergy to aspirin, clopidogrel, and/or alteplase.
  7. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment.
  8. Blood glucose ≤ 2.7 mmol/L.
  9. Epileptic seizures during a stroke attack.
  10. Recent trauma (<15 days).
  11. Recent intracranial or spinal cord surgery, head trauma, or stroke (<3 months).
  12. History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor.
  13. Active visceral hemorrhage (<22 days).
  14. History of anticoagulant use within 24 hours prior to onset.
  15. Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition.
  16. Anticipated life expectancy < 3 months.
  17. Pregnant or lactating women.
  18. Participation in other clinical trials.
  19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DAPT group
Receiving dual antiplatelet therapy immediately after randomization (Oral aspirin 100mg+clopidogrel 300mg, Day 1). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90) and clopidogrel 75mg/d (Day 2-21), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.
Drug: Aspirin
See arm/group descriptions.
Drug: Clopidogrel
See arm/group descriptions.
Active Comparator: IVT group
Receiving intravenous thrombolysis immediately after randomization (Intravenous alteplase, 0.9mg/kg, a maximum dosage of 90mg). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.
Drug: Alteplase
See arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale score (mRS) 0-1
Time Frame: 90(±7) days
The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.
90(±7) days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale score (mRS) 0-1
Time Frame: 7(±1) days
The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first).
7(±1) days
Early neurological deterioration
Time Frame: 7(±1) days
The incidence of early neurological deterioration at 7 days.
7(±1) days
Recurrent stroke
Time Frame: 90(±7) days
The incidence of recurrent stroke at 90 days.
90(±7) days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAFETY OUTCOME: Symptomatic intracranial hemorrhage
Time Frame: 24 (±12) hours
Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
24 (±12) hours
SAFETY OUTCOME: Mortality
Time Frame: 90(±7) days
Mortality at 90 days
90(±7) days
SAFETY OUTCOME: Any intracranial hemorrhage
Time Frame: 24 (±12) hours
Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
24 (±12) hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yamei Tang, Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSKY-2022-252-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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