Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease (SATBRAD)

September 5, 2023 updated by: Chang Gung Memorial Hospital

Early Intensive Medical Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease

Branch atheromatous disease (BAD) has been reported to contribute to small-vessel occlusion and is associated with a higher possibility of early neurological deterioration (END). Because the pathology of BAD is due to atherosclerosis, the investigators postulate that early intensive medical treatment with dual antiplatelet therapy(DAPT) and high-intensity statin may prevent END and recurrent stroke. The investigators hypothesise that intensive medical therapy can prevent END in BAD using aspirin, clopidogrel and high-intensity statin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The SATBRAD study is a single-centre, prospective, open-label, single-group trial with a historical control group of BAD patients treated with single antiplatelet therapy and regular statin treatment in Chang Gung Memorial Hospital in Taiwan.

Eligible participants are as follows:

  1. have a clinical diagnosis of ischemic stroke;
  2. National Institute of Health Stroke Scale (NIHSS) score of 1-8;
  3. an ischemic lesion on diffuse-weighted imaging located in the middle cerebral artery(MCA) perforator, Heubner's artery or vertebrobasilar perforator territories;
  4. BAD, defined by a visible lesion in three or more axial MRI cuts in the MCA perforator territory or Heubner's artery territories or infarcts that extended from the basal surface of the brainstem.
  5. can receive intensive medical treatment within 24 hours of stroke onset.

Participants in the intervention group will receive DAPT and high-intensity statin treatment. DAPT treatment is administered within 24 hours of stroke onset, with aspirin (300 mg loading and 100 mg/day) and clopidogrel (300mg and 75m/day). Participants will take aspirin and clopidogrel for 21 days and then keep aspirin or clopidogrel alone. High-intensity statin is administered, including atorvastatin 40-80mg or rosuvastatin 20 mg for 3 months.

A historical control group of patients receiving single oral antiplatelet medication and regular statin treatment will be drawn from previous prospective observation studies which were executed since Jan. 2011 to Dec. 2020. The total sample sizes are 147 for intervention group and 277 for control group.

The primary endpoint is the composite of END, defined as an increase of ≧2 points of NIHSS within 7 days, and recurrent ischemic stroke within 30 days.

Study Type

Interventional

Enrollment (Estimated)

424

Phase

  • Phase 2

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 Locations

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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke with National Institute of Health Stroke Scale (NIHSS) score of 1-8
  • An ischemic lesion on diffuse-weighted imaging located in the MCA perforator, or Heubner's artery territories or vertebro-basilar perforator territories at brain stem.
  • Branch atheromatous disease, defined by a visible lesion in three or more axial MRI cuts in the MCA perforator or Heubner's artery territories or infarcts that extended from the basal surface of the brainstem.
  • Ability to randomize within 24 hours of time last known free of new ischemic symptoms.
  • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
  • Ability to tolerate high intensity medical therapy, including aspirin at a dose of 50-325 mg/day, clopidogrel with 300mg loading and 75mg after day 2 and high-intensity statin(either atorvastatin 40-80mg or rosuvastatin 20 mg/day).
  • Pre-stroke mRS≦1

Exclusion Criteria:

  • Age < 20 years.
  • In the judgment of the treating physician
  • A candidate for thrombolysis, endarterectomy or endovascular intervention.
  • Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
  • Patients with more than 50% stenosis of the relevant arteries on magnetic resonance angiography (MRA), including intra- or extra-cranial internal carotid artery, middle cerebral artery or basilar artery.
  • Patients with high risk of cardioembolic source, such as atrial fibrillation, acute myocardial infarction, severe heart failure or valvular heart disease.
  • Other determined stroke etiology, such as vasculitis, shock, antiphospholipid antibody syndrome and etc.
  • Gastrointestinal bleed or major surgery within 3 months prior to index event.
  • History of nontraumatic intracranial hemorrhage.
  • Clear indication for anticoagulation during the study period (deep venous thrombosis, pulmonary embolism or hypercoagulable state).
  • Qualifying ischemic event induced by angiography or surgery.
  • Severe non-cardiovascular comorbidity with life expectancy <3 months.
  • Contraindication to clopidogrel, aspirin, atorvastatin or rosuvastatin
  • Known allergy to clopidogrel, aspirin atorvastatin or rosuvastatin
  • Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (INR>1.2; ALT>40 U/L or any resultant complication, such as variceal bleeding, encephalopathy, or jaundice)
  • Hemostatic disorder or systemic bleeding in the past 3 months
  • Current thrombocytopenia (platelet count <100 x109/L) or leukopenia (<2 x109/L)
  • History of drug-induced hematologic or hepatic abnormalities
  • Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (e.g., dipyridamole, ticagrelor, ticlopidine), or NSAIDs.
  • Low-density lipoprotein<70mg/dl without prior statin treatment in recent one year or within 2 days after recruitment

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

This group will receive dual antiplatelet and high-intensity statin treatment.

  • Dual antiplatelet treatment: loading of clopidogrel 300mg plus aspirin 300mg, followed by clopidogrel 75 mg/day and aspirin 100 mg/d from day 2 to day 21, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
  • High-intensity statin treatment: Atorvastatin 40-80mg/day or Rosuvastatin 20 mg/day for 90 days.
Drug: Clopidogrel
300mg loading and 75mg/day from day 2
Drug: Aspirin
Aspirin(100-300mg/day)
Drug: Atorvastatin
Atorvastatin 40-80mg/day
Drug: Rosuvastatin
Rosuvastatin 20 mg/day.
Active Comparator: Historical control
A historical control group of patients receiving single antiplatelet therapy but no high-intensity statin treatment will be drawn from previous prospective observation studies. Antiplatelet therapy includes aspirin(100-300mg/day) or Clopidopgrel (75mg/day).
Drug: Clopidogrel
300mg loading and 75mg/day from day 2
Drug: Aspirin
Aspirin(100-300mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of patients with early neurological deterioration within 7 days and recurrent ischemic stroke within 30 days.
Time Frame: 30 days

The early neurological deterioration is defined as an increase of 2 points of NIHSS.

The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The maximum possible score is 42, with the minimum score being a 0.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total mortality
Time Frame: 90 days
90 days
Percentage of patients with favorable functional recovery defined as a mRS ≦1
Time Frame: 90 days
Defined as a mRS ≦1. The Modified Rankin Scale (mRS) runs from 0-6, running from perfect health without symptoms(score 0) to death(score 6).
90 days
Percentage of patients with new clinical vascular events
Time Frame: 90 days
ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death
90 days
Changes of atherosclerotic plaque
Time Frame: 6 months
The changes of atherosclerotic plaque was measured by high-resolution MRI initially and 6 months later.
6 months
Numbers of moderate to severe bleeding events
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 23, 2021

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 28, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202001386A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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