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

NCT04088513 | Unknown Phase 4 DMC

• 2 other identifiers: SAST2018001
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 19

Brief 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 to evaluate the hemolytic effects of a 3-month regimen of aspirin 100mg/d versus a 3-month regimen of clopidogrel 75mg/d.

Conditions

G6PD Deficiency; Stroke

Keywords

G6PD Deficiency; Acute ischemic stroke; Aspirin; Hemolysis; Clopidogrel; Anti-platelet therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  90±5 days.

Secondary Outcomes (11)

• Change in hemoglobin.

  4 days,10±3 days,27±3 days and 90±5 days.

• Change in reticulocyte.

  4 days,10±3 days,27±3 days and 90±5 days.

• Change in unconjugated bilirubin and total bilirubin.

  4 days,10±3 days,27±3 days and 90±5 days.

• Change in lactic dehydrogenase.

  4 days,10±3 days,27±3 days and 90±5 days.

• Proportion of major bleed (GUSTO definition).

  90±5 days.

Study Arms (2)

Aspirin

EXPERIMENTAL

Drugs:Aspirin

Drug: Aspirin

Clopidogrel

ACTIVE COMPARATOR

Drugs:Clopidogrel

Drug: Clopidogrel

Interventions

Aspirin DRUG

This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.

Also known as: Acetylsalicylic acid

Aspirin

Clopidogrel DRUG

This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.

Also known as: Plavix

Clopidogrel

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (19)

Longyan First Hospital

Longyan, Fujian, China

RECRUITING

Sanming First Hospital

Sanming, Fujian, China

RECRUITING

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

NOT YET RECRUITING

Jieyang Municipal People's Hospital

Jieyang, Guangdong, 522000, China

RECRUITING

Meizhou City People's Hospital

Meizhou, Guangdong, 514000, China

RECRUITING

Yue Bei People's Hospital

Shaoguan, Guangdong, 512026, China

NOT YET RECRUITING

Yunfu People's Hospital

Yunfu, Guangdong, 527300, China

NOT YET RECRUITING

People's Hospital of Baise

Baise City, Guangxi, 533000, China

RECRUITING

The Forth Affiliated Hospital of Guangxi Medical Hospital

Liuchow, Guangxi, 545005, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Beiliu People's Hospital

Yulin, Guangxi, 537400, China

RECRUITING

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570311, China

NOT YET RECRUITING

Fengcheng People's Hospital

Fengcheng, Jiangxi, China

RECRUITING

Ganzhou Municipal Hospital

Ganzhou, Jiangxi, 341000, China

NOT YET RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

RECRUITING

Ganzhou People' Hospital

Ganzhou, Jiangxi, China

RECRUITING

The Forth Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330003, China

NOT YET RECRUITING

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase Deficiency; Stroke; Ischemic Stroke; Hemolysis

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jinsheng Zeng, MD,PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinsheng Zeng, MD,PhD

CONTACT

13322800657; zengjs@pub.guangzhou.gd.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 12, 2019
• Study Start: January 22, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

CN (19)