Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Age: 18-80 years old.
• Acute mild non-cardioembolic stroke.
• NIHSS score ≤5.
• Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
• The investigational drug can be administered within 48 hours of symptom onset.
• Signed informed consent by the patient or legally authorized representative.
Locations
Other Locations
China
WuYuan County People's Hospital
RECRUITING
Bayan Nur
Huai'an First People's Hospital
RECRUITING
Huai'an
Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Jiangsu Province (Suqian) Hospital
RECRUITING
Suqian
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
RECRUITING
Suzhou
Changshu No.1 People's Hospital
RECRUITING
Suzhou
First People's Hospital of Kunshan
RECRUITING
Suzhou
Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Suzhou Municipal Hospital of Anhui Province
RECRUITING
Suzhou
Suzhou Ninth People's Hospital
RECRUITING
Suzhou
Suzhou Xiangcheng People's Hospital
RECRUITING
Suzhou
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
RECRUITING
Suzhou
Zhangjiagang Hospital of Traditional Chinese Medicine
RECRUITING
Suzhou
Taixing Second People's Hospital
RECRUITING
Taizhou
Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Nuclear Industry 417 Hospital
RECRUITING
Xi'an
First People's Hospital of Xianyang
RECRUITING
Xianyang
Taikang Xian People's Hospital
RECRUITING
Zhoukou
Contact Information
Primary
Jijun Shi, M.D
shijijun2008@126.com
+86 512 67783689
Backup
Yongjun Cao, M.D, PhD
yongjuncao@126.com
Time Frame
Start Date: 2025-08-30
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 580
Treatments
Experimental: Tirofiban+Oral Dual Antiplatelet Therapy
Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter
Active_comparator: oral dual antiplatelet therapy
Patients will receive oral dual antiplatelet therapy alone
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital of Soochow University