Last reviewed · How we verify
NCT04028518
A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
Phase 2 trial testing r-PA in Acute Ischemic Stroke in 180 participants. Status unknown.
31 October 2020
Quick facts
| Lead sponsor | Angde Biotech Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 20 July 2019 |
| Primary completion | 31 October 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- r-PA — full drug profile →
- r-PA — full drug profile →
- Alteplase for Injection — full drug profile →
Conditions studied
- Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
Sponsor
Angde Biotech Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial. The secondary purpose of this trial is to compare the safety of different dose of investigational product and comparator product in patients with acute ischemic stroke in 4.5 hours afterstroke onset .
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial.
Li S, Wang X, Jin A, Liu G, et al · · 2024 · cited 19× · PMID 38152962 · DOI 10.1161/strokeaha.123.045193 -
Thrombolytic therapy for patients with acute ischemic stroke: systematic review and network meta-analysis of randomized trials.
Sun LC, Li WS, Chen W, Ren Z, et al · · 2024 · cited 6× · PMID 39839875 · DOI 10.3389/fneur.2024.1490476
Verify or expand the search:
- PubMed search for NCT04028518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Ischemic Stroke
Currently open trials in the same condition.
- NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
- NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
- NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
- NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
- NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting
Other Angde Biotech Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT05629598 — A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia . · Phase 2 · unknown
- NCT05295173 — A Study of r-PA Treating Patients With Acute Ischemic Stroke(RAISE) · Phase 3 · completed
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 NCT04028518 (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 Angde Biotech Pharmaceutical Co., Ltd.
- Last refreshed: 22 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04028518.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing