G6PD DeficiencyPhase 4SASTNCT04088513

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

A Phase 4 study testing Aspirin and Clopidogrel in people with G6PD Deficiency and Stroke, run by First Affiliated Hospital, Sun Yat-Sen University at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: G6PD Deficiency, Stroke
What is being tested?: Aspirin and Clopidogrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 19 sitesChina
Study dates: 22 Jan 2020to 31 Dec 2024
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-ischemic brain disease, base on head CT or MRI
Concomitant infections at the time of randomization
mRS>2 prior to the presenting stroke
Hemoglobin<10 g/dL prior to randomization
Received intravenous thrombolytic therapy or neurointervention treatment before randomization
Clear indication for anticoagulation (presumed cardioembolism, eg, atrial fibrillation, prosthetic cardiac valves or suspected endocarditis)

Show all 21Show fewer

Clear indication for dual antiplatelet therapy (eg, minor stroke in 24h (NIHSS ≤3) or endovascular therapy for the indexed event)
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.
Anticipated concomitant therapy with long-term (>7 days) NSAIDs affecting platelet function
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)
Any history of thalassemia, autoimmune hemolytic disease, aplastic anemia or other severe hematologic diseases
Anticipated concomitant therapy with other contraindicated drugs for G6PD deficiency
Severe dysphagia to unable swallow the drugs
Concomitant infections and need for antimicrobial therapy
Intracranial hemorrhage or gastrointestinal bleed within 3 months, or major surgery within 30 days
Stomach tumor or any other malignant tumor
Planed surgery or interventional treatment that may affect the study procedure
Severe non-cardiovascular comorbidity with life expectancy <3 m
Female who is pregnant or lactating
Currently receiving an investigational drug or device
Inability to understand and/or comply with study procedures due to psychosis, cognition impairment or emotion disturbance.

Trial locations and contacts

19 sites in 1 country.

Jinsheng Zeng, MD,PhD contact

13322800657

zengjs@pub.guangzhou.gd.cn

City, postcode or hospital

Sites recruiting now only

19 sites in 1 country

China19 sites, 19 recruiting

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

Other trials in China

About this study

Official title: 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

Read the 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.

Conditions: G6PD Deficiency, Stroke
Being tested: Aspirin, Clopidogrel
Keywords: G6PD Deficiency, Acute ischemic stroke, Aspirin, Hemolysis, Clopidogrel, Anti-platelet therapy
Medical subject headings: Glucosephosphate Dehydrogenase Deficiency, Stroke, Ischemic Stroke, Hemolysis

What participants receive

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

AspirinDrug
Also called Acetylsalicylic acid
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
ClopidogrelDrug
Also called Plavix
This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.

Study groups in NCT04088513
Study group	Role	What they receive
Aspirin	Experimental	Drugs:Aspirin Receives: Drug: Aspirin
Clopidogrel	Active comparator	Drugs:Clopidogrel Receives: Drug: Clopidogrel

What is being measured

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

Proportion of protocol-defined hemolysis.
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.
Measured: 90±5 days.

Secondary outcomes (11)

Change in hemoglobin.
Measured: 4 days,10±3 days,27±3 days and 90±5 days.
Change in reticulocyte.
Measured: 4 days,10±3 days,27±3 days and 90±5 days.
Change in unconjugated bilirubin and total bilirubin.
Measured: 4 days,10±3 days,27±3 days and 90±5 days.
Change in lactic dehydrogenase.
Measured: 4 days,10±3 days,27±3 days and 90±5 days.
Proportion of major bleed (GUSTO deﬁnition).
Measured: 90±5 days.
Overall mortality.
Measured: 90±5 days.
Proportion of new clinical vascular events, deﬁned as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death.
Measured: 90±5 days.
Proportion of functional independence defined as modified Rankin Scale score 0-2.
Modified Rankin Scale score ranges from 0 to 6, and lower score means more functional independence.
Measured: 90±5 days.
Proportion of functional independence defined as Barthel Index 95-100.
Barthel Index ranges from 0 to 100, and higher score means more functional independence.
Measured: 90±5 days.
Change in National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher scores indicate more severe neurologic deficits.
Measured: 90±5 days.
Health related quality of life, assessed by EuroQoL-5 Dimensions questionnaire
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.
Measured: 90±5 days.

Timeline

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

22 Jan 202031 Dec 2024

First posted12 Sep 2019
Study start22 Jan 2020
Primary completion31 Dec 2024 (estimated)
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for G6PD DeficiencyStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 440 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04088513
Sponsor's protocol ID: SAST
Other IDs: 2018001
Acronym: SAST
Status last verified: Mar 2022
First submitted: 8 Sep 2019
Last updated: 16 Mar 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Jinsheng Zeng, MD,PhD

13322800657

zengjs@pub.guangzhou.gd.cn

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

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All G6PD Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04088513
Acronym / sponsor ID: SAST / SAST
Conditions: G6PD Deficiency, Stroke
Keywords: G6PD Deficiency, Acute ischemic stroke, Aspirin, Hemolysis, Clopidogrel, Anti-platelet therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 440 participants (estimated)
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 22 Jan 2020 (actual)
Primary completion: 31 Dec 2024 (estimated)
Study completion: 31 Dec 2024 (estimated)
First posted: 12 Sep 2019 (actual)
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.

Detailed description

Study design

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

Arm	Type	Receives
Aspirin	Experimental	Drug: AspirinDrugs:Aspirin
Clopidogrel	Active comparator	Drug: ClopidogrelDrugs:Clopidogrel

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (21 listed)

Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-ischemic brain disease, base on head CT or MRI
Concomitant infections at the time of randomization
mRS>2 prior to the presenting stroke
Hemoglobin<10 g/dL prior to randomization
Received intravenous thrombolytic therapy or neurointervention treatment before randomization

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
AspirinAlso: Acetylsalicylic acidThis group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.	Drug	Aspirin
ClopidogrelAlso: PlavixThis group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.	Drug	Clopidogrel

Primary outcome

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.

11 secondary outcomes

Change in hemoglobin.
Time frame: 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.
Change in unconjugated bilirubin and total bilirubin.
Time frame: 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.
Proportion of major bleed (GUSTO deﬁnition).
Time frame: 90±5 days.
Overall mortality.
Time frame: 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.
Proportion of functional independence defined as modified Rankin Scale score 0-2.
Time frame: 90±5 days.
Proportion of functional independence defined as Barthel Index 95-100.
Time frame: 90±5 days.
Change in National Institutes of Health Stroke Scale
Time frame: 90±5 days.
Health related quality of life, assessed by EuroQoL-5 Dimensions questionnaire
Time frame: 90±5 days.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.

Related trials for G6PD Deficiency

RecruitingPhase 3
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Malaria Vivax, Malaria Falciparum
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruitingPhase 1
High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study
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Recruiting
The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
Hyperbilirubinemia, Neonatal Indirect
RecruitingPhase 4
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.
Vivax Malaria, G6PD Deficiency

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.

Jinsheng Zeng, MD,PhD contact

13322800657

zengjs@pub.guangzhou.gd.cn

Jinsheng Zeng, MD,PhD principal investigator

First Affiliated Hospital, Sun Yat-Sen University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin and Clopidogrel in people with G6PD Deficiency and Stroke, run by First Affiliated Hospital, Sun Yat-Sen University at 19 sites in China.

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 21 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: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. 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?

Results are not available in the source record.

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

Contact Jinsheng Zeng, MD,PhD (13322800657, zengjs@pub.guangzhou.gd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of protocol-defined hemolysis. (time frame: 90±5 days.). 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 NCT04088513.

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 16 Mar 2022.