Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST) (SAST)

March 15, 2022 updated by: Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

A Randomized, Double-blind, Active-Controlled Trial Comparing the Safety and Efficacy of Aspirin Versus Clopidogrel in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency

Aspirin was reported to induce hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency on some occasions, while still widely uesd for stroke prevention. The SAST trial is designed to evaluate the safety and efficacy of aspirin in patients this enzyme disorder.The primary purpose of the trial is to evaluate the hemolytic effects of a 3-month regimen of aspirin 100mg/d versus a 3-month regimen of clopidogrel 75mg/d.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

This SAST trial is a prospective, multicenter, randomized, double-blind trial.440 acute ischemic stroke (AIS) patients with G6PD deficiency will be randomized to receive a 3-month regimen of aspirin 100mg/d or clopidogrel 75mg/d. The primary end point is the proportion of protocol-defined hemolysis at 90 days. Protocol-defined hemolysis is defined as one or more of the following conditions: a) Hemoglobin level declined ≥2.5 g/dL from baseline, meanwhile ruling out bleeding events. b) Hemoglobin level declined ≥25% from baseline, meanwhile ruling out bleeding events. c) Clinically relevant hemolytic events, could manifested as fatigue, back pain, anemia, dark urine and jaundice. The study consists of five visits including the day of randomization, day 4, day10±3days, day27±3days, day90±7days.

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 (Anticipated)

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.
440

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
    • Fujian
      • Longyan, Fujian, China
        • Recruiting
        • Longyan First Hospital
        • Contact:
          • Yangui Chen
      • Sanming, Fujian, China
        • Recruiting
        • SanMing First Hospital
        • Contact:
          • Weimin Hong
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
      • Guangzhou, Guangdong, China, 510632
        • Not yet recruiting
        • The First Affiliated Hospital of Jinan University
      • Jieyang, Guangdong, China, 522000
        • Recruiting
        • Jieyang Municipal People's Hospital
        • Contact:
          • Jiakai Li
      • Meizhou, Guangdong, China, 514000
        • Recruiting
        • Meizhou City People's Hospital
      • Shaoguan, Guangdong, China, 512026
        • Not yet recruiting
        • Yue Bei People's Hospital
      • Yunfu, Guangdong, China, 527300
        • Not yet recruiting
        • Yunfu People's Hospital
    • Guangxi
      • Baise, Guangxi, China, 533000
        • Recruiting
        • People's Hospital of Baise
        • Contact:
          • Dengrong Ban
      • Liuzhou, Guangxi, China, 545005
        • Recruiting
        • The Forth Affiliated Hospital of Guangxi Medical Hospital
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical Hospital
      • Yulin, Guangxi, China, 537400
        • Recruiting
        • Beiliu People's Hospital
        • Contact:
          • Bin Chen
    • Hainan
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • The Second Affiliated Hospital of Hainan Medical University
    • Jiangxi
      • Fengcheng, Jiangxi, China
        • Recruiting
        • Fengcheng People's Hospital
        • Contact:
          • Hongxing Huang
      • Ganzhou, Jiangxi, China, 341000
        • Not yet recruiting
        • Ganzhou Municipal Hospital
      • Ganzhou, Jiangxi, China
        • Recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Contact:
          • Zheng Liu
      • Ganzhou, Jiangxi, China
        • Recruiting
        • Ganzhou People' Hospital
        • Contact:
          • Xianghong Liu
      • Nanchang, Jiangxi, China, 330003
        • Not yet recruiting
        • The Forth Affiliated Hospital of Nanchang 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

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age≥40 years(no upper limit)
  2. Acute ischemic stroke within 14 days of symptoms onset;
  3. Glucose-6-phosphate dehydrogenase deficiency screened in G6PD enzyme activity
  4. Had not received aspirin 7 days prior to randomization
  5. Informed consent signed

Exclusion Criteria:

  1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-ischemic brain disease, base on head CT or MRI
  2. Concomitant infections at the time of randomization
  3. mRS>2 prior to the presenting stroke
  4. Hemoglobin<10 g/dL prior to randomization
  5. Received intravenous thrombolytic therapy or neurointervention treatment before randomization
  6. Clear indication for anticoagulation (presumed cardioembolism, eg, atrial fibrillation, prosthetic cardiac valves or suspected endocarditis)
  7. Clear indication for dual antiplatelet therapy (eg, minor stroke in 24h (NIHSS ≤3) or endovascular therapy for the indexed event)
  8. Anticipated concomitant antiplatelets other than aspirin or clopidogrel (eg, GPIIb/IIIa inhibitors, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents.
  9. Anticipated concomitant therapy with long-term (>7 days) NSAIDs affecting platelet function
  10. Contraindication to clopidogrel or aspirin (1)Known allergic reactions (2)Severe hepatic or renal dysfunction (Severe hepatic dysfunction is defined as serum ALT or AST >2 times the upper limit of the normal group；Severe renal dysfunction is defined as serum creatinine > 1.5 times the upper limit of the normal group) (3)Severe cardiac failure（NYHA class Ⅲ or Ⅳ) (4)Asthma (5)Any history of Hemostatic disorder or systemic bleeding (6)Any history of thrombocytopenia or neutropenia (7)Any history of drug-induced hematologic or hepatic insufficiency (8)Low white blood cell (<2×10^9/L) or platelet count (<100×10^9/L)
  11. Any history of thalassemia, autoimmune hemolytic disease, aplastic anemia or other severe hematologic diseases
  12. Anticipated concomitant therapy with other contraindicated drugs for G6PD deficiency
  13. Severe dysphagia to unable swallow the drugs
  14. Concomitant infections and need for antimicrobial therapy
  15. Intracranial hemorrhage or gastrointestinal bleed within 3 months, or major surgery within 30 days
  16. Stomach tumor or any other malignant tumor
  17. Planed surgery or interventional treatment that may affect the study procedure
  18. Severe non-cardiovascular comorbidity with life expectancy <3 m
  19. Female who is pregnant or lactating
  20. Currently receiving an investigational drug or device
  21. Inability to understand and/or comply with study procedures due to psychosis, cognition impairment or emotion disturbance.

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: Quadruple

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: Aspirin
Drugs:Aspirin
Drug: Aspirin
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
Other Names:
  • Acetylsalicylic acid
Active Comparator: Clopidogrel
Drugs:Clopidogrel
Drug: Clopidogrel
This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.
Other Names:
  • Plavix

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
Proportion of protocol-defined hemolysis.
Time Frame: 90±5 days.
Protocol-defined hemolysis is defined as one or more of the following conditions: a) Hemoglobin level declined ≥2.5 g/dL from baseline, meanwhile ruling out bleeding events. b) Hemoglobin level declined ≥25% from baseline, meanwhile ruling out bleeding events. c) Clinically relevant hemolytic events, could manifested as fatigue, back pain, anemia, dark urine and jaundice, adjudicated by the adjudication committee ultimately.
90±5 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
Change in hemoglobin.
Time Frame: 4 days,10±3 days,27±3 days and 90±5 days.
4 days,10±3 days,27±3 days and 90±5 days.
Change in reticulocyte.
Time Frame: 4 days,10±3 days,27±3 days and 90±5 days.
4 days,10±3 days,27±3 days and 90±5 days.
Change in unconjugated bilirubin and total bilirubin.
Time Frame: 4 days,10±3 days,27±3 days and 90±5 days.
4 days,10±3 days,27±3 days and 90±5 days.
Change in lactic dehydrogenase.
Time Frame: 4 days,10±3 days,27±3 days and 90±5 days.
4 days,10±3 days,27±3 days and 90±5 days.
Proportion of major bleed (GUSTO definition).
Time Frame: 90±5 days.
90±5 days.
Overall mortality.
Time Frame: 90±5 days.
90±5 days.
Proportion of new clinical vascular events, defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death.
Time Frame: 90±5 days.
90±5 days.
Proportion of functional independence defined as modified Rankin Scale score 0-2.
Time Frame: 90±5 days.
Modified Rankin Scale score ranges from 0 to 6, and lower score means more functional independence.
90±5 days.
Proportion of functional independence defined as Barthel Index 95-100.
Time Frame: 90±5 days.
Barthel Index ranges from 0 to 100, and higher score means more functional independence.
90±5 days.
Change in National Institutes of Health Stroke Scale
Time Frame: 90±5 days.
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher scores indicate more severe neurologic deficits.
90±5 days.
Health related quality of life, assessed by EuroQoL-5 Dimensions questionnaire
Time Frame: 90±5 days.
EuroQoL-5 Dimensions questionnaire contains utility index score and visual analogue scale. Utility index score ranges from 0 to 1, and visual analogue scale ranges from 0 to 100. Higher scores indicate more healthy quality of life.
90±5 days.

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.
First Affiliated Hospital, 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: Jinsheng Zeng, MD,PhD, First Affiliated 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 (Actual)

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.
January 22, 2020

Primary Completion (Anticipated)

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.
December 31, 2024

Study Completion (Anticipated)

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.
December 31, 2024

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).
September 8, 2019

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.
September 11, 2019

First Posted (Actual)

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.
September 12, 2019

Study Record Updates

Last Update Posted (Actual)

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.
March 16, 2022

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.
March 15, 2022

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.
March 1, 2022

More Information

Terms related to this study

Keywords

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.
  • SAST
  • 2018001 (Sun Yat-Sen University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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