Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Last updated: November 11, 2024
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Cardiac Ischemia

Thrombosis

Treatment

Best medical management

Placebo

Aspirin

Clinical Study ID

NCT06548971
TREND-IVT
  • Ages > 18
  • All Genders

Study Summary

Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis.

Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear.

The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old;

  2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase ortenecteplase within 4.5 hours of onset or time last known well and can receive thestudy drug treatment within 3 hours of initiating intravenous thrombolysis.

  3. NIHSS score improvement ≤ 2 points or worsening ≤ 4 points one hour after initiatingintravenous thrombolysis compared to pre-thrombolysis.

  4. Residual NIHSS score > 5 points at randomization.

  5. Informed consent obtained from patients or their acceptable surrogates.

Exclusion

Exclusion Criteria:

  1. Stroke caused by definite large vessel occlusion (including A1 and A2 segments ofthe anterior cerebral artery, M1 and M2 segments of the middle cerebral artery, P1and P2 segments of the posterior cerebral artery, intracranial and extracranialsegments of the internal carotid artery, basilar artery, and bilateral vertebralartery occlusion) confirmed by imaging (including CTA or MRA).

  2. Scheduled for endovascular treatment.

  3. Intracranial hemorrhage confirmed by imaging post-thrombolysis.

  4. Definite or suspected cardioembolic stroke.

  5. Stroke caused by other determined causes, including moyamoya disease, arterydissection, arteritis, etc.

  6. Pre-stroke mRS score > 1.

  7. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2points.

  8. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsibleartery supply area.

  9. Prior history of stroke events (manifesting as stroke symptoms, includinghemorrhagic stroke and ischemic stroke).

  10. Known contraindications for antiplatelet therapy, such as coagulation disorders,systemic bleeding, etc.

  11. History of aspirin allergy.

  12. Use of antiplatelet or anticoagulant therapy within one week pre-stroke.

  13. There is definite anticipation of developing indications for anticoagulant therapyduring the study period (e.g., atrial fibrillation, mechanical heart valve, deepvein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulablestate).

  14. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR < 30 ml/min or serum Cr > 220 μmol/L (2.5 mg/dl)), severe hepatic insufficiency (serum ALT > 2 times the upper limit of normal, or serum AST > 2 times the upperlimit of normal), severe heart failure (NYHA class III or IV).

  15. Severe non-cardiovascular complications with an expected survival of less than 6months.

  16. Unavailability for follow-up.

  17. Presence of dementia, psychiatric disorders, or other known neurological conditionsthat complicate follow-up.

  18. Current participation in another therapeutic study with ongoing treatment andfollow-up.

  19. Other conditions that are not suitable for participation in this study as determinedby the investigator.

Study Design

Total Participants: 1184
Treatment Group(s): 3
Primary Treatment: Best medical management
Phase: 3
Study Start date:
November 07, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • The Third The People's Hospital Of Bengbu

    Bengbu, Anhui 233000
    China

    Site Not Available

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College

    Chongqing, Chongqing 401121
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • The Second People's Hospital Of Qinzhou

    Qinzhou, Guangxi 535099
    China

    Site Not Available

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi 543002
    China

    Site Not Available

  • The First Hospital Of Qiqihar

    Qiqihar, Heilongjiang 161005
    China

    Site Not Available

  • Luoyang Yanshi People's Hospital

    Luoyang, Henan 471900
    China

    Active - Recruiting

  • Xihua People's Hospital

    Zhoukou, Henan 466000
    China

    Site Not Available

  • Liuyang Jili Hospital

    Liuyang, Hunan 410300
    China

    Active - Recruiting

  • Xiangtan Central Hospital

    Xiangtan, Hunan 411100
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412007
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia University for the Nationalities

    Tongliao, Inner Mongolia 028007
    China

    Active - Recruiting

  • Ulanqab Central Hospital

    Ulanqab, Inner Mongolia 012000
    China

    Site Not Available

  • Zha Lan Tun Shi Zhong Meng Yi Yuan

    Zhalantun, Inner Mongolia 162650
    China

    Active - Recruiting

  • Jingdezhen NO.1 People's Hospital

    Jingdezhen, Jiangxi 333000
    China

    Active - Recruiting

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi 330008
    China

    Site Not Available

  • Jinan Third People's Hospital

    Jinan, Shandong 250101
    China

    Site Not Available

  • The Third People Hospital In Liaocheng

    Liaocheng, Shandong 252000
    China

    Active - Recruiting

  • Weihai Municipal Hospital

    Weihai, Shandong 264200
    China

    Active - Recruiting

  • The People's Hospital Of Leshan

    Leshan, Sichuan 614000
    China

    Site Not Available

  • Shihezi City People's Hospital

    Shihezi, Xinjiang 832000
    China

    Site Not Available

  • Haiyan People's Hospital

    Jiaxing, Zhejiang 314311
    China

    Active - Recruiting

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