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> Record changed: 2026-11-04

# A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke

NCT05188417

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Recruitment status

Unknown

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Participants

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Lead sponsor

GrandPharma (China) Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Start date

2021-12-09

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Title and summary

**Summary**

The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with alteplase in acute ischemic stroke

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Acronym**

RESET

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Short title**

A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Official title**

A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Intravenous Thrombolytic Therapy With Alteplase in Acute Ischemic Stroke

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Recruitment status**

Unknown

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Dates

**Completion date**

2023-06-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**First posted**

2022-01-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Registry last updated**

2023-02-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Primary completion date**

2023-03-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Start date**

2021-12-09

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Size and sites

**Actual participants**

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Participants**

266

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Lead sponsor**

GrandPharma (China) Co., Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Identifiers

**Registry ID**

NCT05188417

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**ClinicalTrials.gov ID**

NCT05188417

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Outcomes

### Primary outcomes

1. The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration

### Secondary outcomes

1. The incidence of intracranial hemorrhage (Heidelberg bleeding classification) within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration
2. The incidence of serious bleeding events (GUSTO defined, including fatal and symptomatic intracranial hemorrhage)within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration
3. The incidence of parenchymal hemorrhage type 2 (PH-2) within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration
4. The incidence of moderate bleeding (GUSTO defined) within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration
5. The number of adverse events/serious adverse events reported by the investigator throughout the study period (e.g., absolute value of platelet ≤ 90 × 109/L; hypersensitivity; renal failure, etc.)  
Timeframe: 90 days after the start of administration
6. All-cause mortality 90 days after the start of administration  
Timeframe: 90 days after the start of administration
7. The proportion of subjects with mRS 0-1 score on the modified Rankin scale 90 days after the start of administration  
Timeframe: 90 days after the start of administration
8. The value of change in National Institutes of Health Stroke Scale (NIHSS) score (0-42, higher scores mean a worse outcome) from baseline at 48 hours, 7 and 14 days after the start of administration  
Timeframe: 48 hours, 7 and 14 days after the start of administration
9. Proportion of subjects whose NIHSS scores decrease by ≥ 2 points from baseline or recover to 0-1 point at 48 hours,7 and 14 days after the start of administration  
Timeframe: 48 hours, 7 and 14 days after the start of administration
10. The incidence of worsening stroke (NIHSS score increases by ≥ 4 points, and the cause by cerebral hemorrhage is excluded) within 48 hours after the start of administration  
Timeframe: 48 hours after the start of administration
11. Barthel Index (BI) score (0-100, higher scores mean a better outcome) 90 days after the start of administration  
Timeframe: 90 days after the start of administration
12. The incidence of new vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, and cardio-cerebral revascularization) within 90 days after the start of administration  
Timeframe: 90 days after the start of administration
13. EuroQol Five Dimensions Questionnaire (EQ-5D) (0-100, higher scores mean a better outcome) 90 days after the start of administration  
Timeframe: 90 days after the start of administration
14. Platelet aggregation rate 30 minutes after the start of administration, immediately after the end of administration (i.e.,24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)  
Timeframe: 30 minutes after the start of administration, immediately after the end of administration (i.e., 24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

1. According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
2. ≥ 18 years of age, regardless of gender;
3. Patients who have received or are scheduled to receive intravenous thrombolysis with alteplase, that is, receiving thrombolysis with alteplase within 4.5 hours of onset of ischemic stroke;
4. Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;
5. NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;
6. Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1 point);
7. The subject or his/her guardian participates voluntarily and signs the ICF.

### Exclusion criteria

1. Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);
2. CT suggests large-area anterior circulation infarction (ASPECT score is < 6 points or infarction volume is ≥ 70 mL or infarction area is > 1/3 of the middle cerebral artery blood supply area);
3. Significant head trauma or stroke within 3 months prior to screening;
4. Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);
5. Previous intracranial tumor, arteriovenous malformation or aneurysm;
6. Intracranial or spinal surgery and biopsy within 3 months prior to screening;
7. Prolonged or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the past 10 days or recent puncture of a non-compression vessel (e.g., subclavian vein or jugular vein);
8. Presence of active internal hemorrhage (e.g., gastrointestinal, urinary tract or retinal hemorrhage, etc.);
9. Hemorrhagic tendency (including but not limited to): platelet count < 100 × 109/L during screening; heparin treatment within the last 48 hours and APTT exceeding the upper limit of laboratory normal value; oral administration of warfarin at the time of screening, INR > 1.7; oral administration of new anticoagulants; and using direct thrombin or factor Xa inhibitors;
10. Hypertension is not controlled after active antihypertensive therapy: systolic blood pressure is ≥ 180 mmHg or diastolic blood pressure is ≥ 100 mmHg;
11. Blood glucose concentration is < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
12. Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
13. Serious renal insufficiency (creatinine clearance rate is < 30 mL/min);
14. Currently undergoing renal dialysis;
15. Aortic dissection;
16. Major surgery or serious trauma within 30 days prior to screening;
17. Gastrointestinal or urethral hemorrhage within 30 days prior to screening;
18. History of acute myocardial infarction within 3 months prior to screening;
19. It is known at the time of screening that subjects plan to undergo coronary, carotid or peripheral arterial revascularization during the trial;
20. Female subjects who are serum pregnancy test positive, pregnant/lactating women, or women of childbearing potential who plan to have a pregnancy during the 12-month period, or women of childbearing potential or male subjects who are unwilling to take appropriate contraceptive measures during the trial;
21. Users who are known to be allergic or contraindicated to the investigational product;
22. Life expectancy of < 6 months due to any advanced disease;
23. Patients who have participated in drug or device trials within one month;
24. Patients with poor peripheral venous filling who cannot establish two standard peripheral venous lines;
25. Stroke accompanied by seizures;
26. Other conditions that the investigator considers inappropriate for participation in the clinical study, such as inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Sites

- 23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou DistrictWuhan, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05188417)

## Related records

### Drugs (2)

- [Sodium chloride](https://trialight.com/data/asset/sodium-chloride-a67c33bc-45ef-42e4-8022-d121f0a86585.md)
- [Tirofiban](https://trialight.com/data/asset/tirofiban-922283ae-e04a-47c1-9941-cc6846a3635c.md)

### Lead sponsors (1)

- [GrandPharma (China) Co., Ltd.](https://trialight.com/data/company/grandpharma-china-co-ltd-aeb7bc90-524a-4b0c-bab6-701acc78f28c.md)

### Conditions (1)

- [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) Primary condition

### Targets (2)

- [ITGA2B](https://trialight.com/data/target/itga2b-2b08bd62-aa66-51b5-af80-a8e0e66c7ac3.md)
- [ITGB3](https://trialight.com/data/target/itgb3-8d05de84-876f-5d95-b273-23919b11b6a3.md)

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