NCT06134622CompletedPhase 3
Advancing Stroke Safety and Efficacy Through Early Tirofiban Administration After Intravenous Thrombolysis (ASSET-IT)
Source: ClinicalTrials.gov · Last updated 4 May 2025
Brief summary (registry, in English)
To assess the efficacy and safety of tirofiban administration after intravenous thrombolysis for patients with AIS.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 832 (actual)
- First submitted
- 12 Nov 2023
- Start date
- 14 Mar 2024
- Primary completion date
- 25 Sept 2024
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Diseases
- Stroke
- NCT number
- NCT06134622
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 832
- From 14 Mar 2024 to the primary completion date, 25 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pre-stroke mRS score \> 1;
- Patients with a history of atrial fibrillation or emergency ECG indicating atrial fibrillation;
- If NIHSS worsens by 2 or more points between start of thrombolysis and start of study drug, repeat brain imaging rules out new intracranial hemorrhage;
- Known allergy to tirofiban or other IIb/IIIa inhibitors;
Lab values
- Known genetic or acquired bleeding diathesis, or received warfarin and INR \> 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
- Severe renal failure, defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate \[GFR\] \< 30, or patients requiring hemodialysis or peritoneal dialysis;
- Liver dysfunction (ALT \> 2 times the upper limit of normal or AST \> 2 times the upper limit of normal);
Other
- Presence of contraindications to intravenous thrombolysis;
- Patients planned to undergo mechanical thrombectomy or other endovascular treatments (e.g., intra-arterial thrombolysis);
- Pregnant or lactating women;
- NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6;
- Severe leukoaraiosis;
- Currently participating in other clinical trials;
- Life expectancy \< 1 year;
- Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patients, etc.).
Who the study is looking for
- Onset of ischemic stroke symptoms within ≤ 4.5 hours\*, treated with intravenous rt-PA or TNK according to guidelines;
- NIHSS score of 4-25 before intravenous thrombolysis;
- Age ≥ 18 years;
- Able to receive the designated study drug within 60 minutes after intravenous thrombolysis;
- Informed consent signed by the patient or their legal representative. \*Symptom onset is defined as the last known well time.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.