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NCT03871517
INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
Phase 4 trial testing Indobufen in Ischemic Stroke in 5,438 participants. Completed in 1 December 2022.
1 March 2022
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 5,438 |
| Start date | 3 June 2019 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
- Indobufen — all drugs for Indobufen →
- Aspirin — all drugs for Aspirin →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 18 to 80, any sex, with Ischemic Stroke or Indobufen. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor diseases as the first cause of death and disability in adult population. The primary purpose of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a 3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Systemic inflammation after stroke: implications for post-stroke comorbidities.
Simats A, Liesz A. · · 2022 · cited 179× · PMID 35971650 · DOI 10.15252/emmm.202216269 -
Indobufen versus aspirin in patients with acute ischaemic stroke in China (INSURE): a randomised, double-blind, double-dummy, active control, non-inferiority trial.
Pan Y, Meng X, Yuan B, Johnston SC, et al · · 2023 · cited 25× · PMID 37121237 · DOI 10.1016/s1474-4422(23)00113-8 -
Indobufen versus aspirin in acute ischaemic stroke (INSURE): rationale and design of a multicentre randomised trial.
Pan Y, Meng X, Chen W, Jing J, et al · · 2022 · cited 7× · PMID 35393360 · DOI 10.1136/svn-2021-001480 -
Effect of Stroke Severity on Efficacy and Safety of Indobufen versus Aspirin in Patients with Moderate to Severe Stroke: Results from the INSURE Randomized Clinical Trial.
Wang M, Pu S, Jin A, Johnston SC, et al · · 2025 · PMID 40707193 · DOI 10.5551/jat.65723
Verify or expand the search:
- PubMed search for NCT03871517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Indobufen
Trials testing the same drug.
- NCT06451198 — IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome · Phase 4 · recruiting
- NCT04308551 — Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease · NA · withdrawn
Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
- NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
- NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
- NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
- NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
- NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting
Other Beijing Tiantan Hospital trials
Trials by the same sponsor.
- NCT07341854 — Dexamethasone Palmitate for Postoperative Pain · NA · not yet recruiting
- NCT07527013 — Stratified Blood Pressure Management Strategy After Endovascular Treatment for Acute Ischemic Stroke · Phase 3 · not yet recruiting
- NCT07520370 — Effect of Perioperative Ulinastatin on Postoperative Stroke in Patients With Brain Tumor · NA · not yet recruiting
- NCT07526987 — Efficacy and Safety of Minocycline in Patients With Acute Ischaemic Stroke Receiving Intravenous Thrombolysis · Phase 3 · not yet recruiting
- NCT07591207 — The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03871517 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 9 January 2023
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