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New treatment option for Acute Ischemic Stroke
Official title Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
ClinicalTrials.gov ID: NCT06548971
What this study is testing
What is Aspirin?
Aspirin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old;
- Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can...
- Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
- Informed consent obtained from patients or an authorized representative.
You likely can't join if
- Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral...
- Intracranial hemorrhage confirmed by imaging post-thrombolysis.
- Definite or suspected cardioembolic stroke.
- Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis)...
- Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with...
- Prior history of moderate or severe ischemic stroke events with residual neurological disability.
See the full eligibility criteria
- Age ≥18 years old;
- Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating...
- Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization.
- Informed consent obtained from patients or an authorized representative.
- Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery...
- Intracranial hemorrhage confirmed by imaging post-thrombolysis.
- Definite or suspected cardioembolic stroke.
- Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders.
- Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)\>1.7.
- Prior history of moderate or severe ischemic stroke events with residual neurological disability.
- Pre-stroke mRS score \> 1.
- Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points.
- Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area.
- Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding
- History of aspirin allergy.
- Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state)
- Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \ 220 μmol/L [2.5 mg/dL]), severe hepatic insufficiency (serum alanine aminotransferase [ALT] \>2 times the upper limit of normal, or...
- Severe non-cardiovascular complications with an expected survival of less than 6 months.
- Unavailability for follow-up.
- Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
- Current participation in another therapeutic study with ongoing treatment and follow-up.
- Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Suzhou, Anhui, China
- Beijing, Beijing Municipality, China
- Haidian, Beijing Municipality, China
- Pinggu, Beijing Municipality, China
- Tongzhou, Beijing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Zhangzhou, Fujian, China
- Guangzhou, Guangdong, China
- Guigang, Guangxi, China
- Wuzhou, Guangxi, China
- Kaili, Guizhou, China
- Haikou, Hainan, China
- Cangzhou, Hebei, China
- Handan, Hebei, China
- Qiqihar, Heilongjiang, China
- Anyang, Henan, China
- Hebi, Henan, China
- Jiangzuo, Henan, China
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Suzhou, Anhui, China; Beijing, Beijing Municipality, China; Haidian, Beijing Municipality, China; Pinggu, Beijing Municipality, China; Tongzhou, Beijing Municipality, China and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.