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Trial record 12 of 615 for:    ASPIRIN AND clopidogrel

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

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ClinicalTrials.gov Identifier: NCT04088513
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
G6PD Deficiency Stroke Drug: Aspirin Drug: Clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: Aspirin
Drugs:Aspirin
Drug: Aspirin
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
Other Name: 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 Name: Plavix




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in hemoglobin. [ Time Frame: 4 days,10±3 days,27±3 days and 90±5 days. ]
  2. Change in reticulocyte. [ Time Frame: 4 days,10±3 days,27±3 days and 90±5 days. ]
  3. Change in unconjugated bilirubin and total bilirubin. [ Time Frame: 4 days,10±3 days,27±3 days and 90±5 days. ]
  4. Change in lactic dehydrogenase. [ Time Frame: 4 days,10±3 days,27±3 days and 90±5 days. ]
  5. Proportion of major bleed (GUSTO definition). [ Time Frame: 90±5 days. ]
  6. Overall mortality. [ Time Frame: 90±5 days. ]
  7. 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. ]
  8. 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.

  9. 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.

  10. 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.

  11. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 90 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088513


Contacts
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Contact: Jinsheng Zeng, MD,PhD 13322800657 zengjs@pub.guangzhou.gd.cn

Locations
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China, Guangdong
The First Affiliated Hospital of Guangdong Pharmaceutical University Not yet recruiting
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital of Jinan University Not yet recruiting
Guangzhou, Guangdong, China, 510632
Jieyang Municipal People's Hospital Not yet recruiting
Jieyang, Guangdong, China, 522000
Meizhou City People's Hospital Not yet recruiting
Meizhou, Guangdong, China, 514000
Yue Bei People's Hospital Not yet recruiting
Shaoguan, Guangdong, China, 512026
Yunfu People's Hospital Not yet recruiting
Yunfu, Guangdong, China, 527300
China, Guangxi
The Forth Affiliated Hospital of Guangxi Medical Hospital Not yet recruiting
Liuzhou, Guangxi, China, 545005
The First Affiliated Hospital of Guangxi Medical Hospital Not yet recruiting
Nanning, Guangxi, China, 530021
China, Hainan
The Second Affiliated Hospital of Hainan Medical University Not yet recruiting
Haikou, Hainan, China, 570311
China, Jiangxi
Ganzhou Municipal Hospital Not yet recruiting
Ganzhou, Jiangxi, China, 341000
The Forth Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, Jiangxi, China, 330003
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Jinsheng Zeng, MD,PhD First Affiliated Hospital, Sun Yat-Sen University

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Responsible Party: Jinsheng Zeng, MD, PhD, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04088513     History of Changes
Other Study ID Numbers: SAST
2018001 ( Other Grant/Funding Number: Sun Yat-Sen University )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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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
Keywords provided by Jinsheng Zeng, MD, PhD, First Affiliated Hospital, Sun Yat-Sen University:
G6PD Deficiency
Acute ischemic stroke
Aspirin
Hemolysis
Clopidogrel
Anti-platelet therapy
Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Stroke
Glucosephosphate Dehydrogenase Deficiency
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors