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Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis

NCT03635749 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6100

Last updated 2023-07-18

No results posted yet for this study

Summary

Large-artery stenosis plays an important role in the occurrence of ischemic stroke. The primary purpose of this study is to evaluate the efficacy and safety of intensive antiplatelet therapy versus standard antiplatelet therapy and immediate high-intensity statin therapy (80mg atorvastatin) versus delayed high-intensity statin therapy (40mg atorvastatin) and intensive antiplatelet combined with immediate high-intensity statin therapy (80mg atorvastatin) versus standard antiplatelet combined with delayed high-intensity statin therapy (40mg atorvastatin) in reducing the risk of stroke at 90 days in patients with acute and high-risk symptomatic extracranial or intracranial arterial stenosis.

Conditions

  • Acute Stroke
  • Transient Ischemic Attack

Interventions

DRUG

Intensive antiplatelet

Day 1：clopidogrel 300mg/day+ aspirin100-300mg/ day Day2 - 21: clopidogrel 75mg/day+ aspirin 100mg/day Day22 - 90: clopidogrel 75mg/day+aspirin placebo

DRUG

Standard antiplatelet

Day 1: Aspirin 100-300mg/day + clopidogrel placebo Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo

DRUG

Immediate high-intensity statin

Day 1 - 21：Atorvastatin calcium 80mg/day Day 22 - 90：Atorvastatin calcium 40mg/day

DRUG

Delayed high-intensity statin

Day 1 - 3：Atorvastatin calcium placebo Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo Day 22 - 90：Atorvastatin calcium 40mg/day

Sponsors & Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

    collaborator OTHER_GOV

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yilong Wang, MD, PhD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2023-01-15
Completion
2023-10-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635749 on ClinicalTrials.gov