A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke
- 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
- Acronym
- RESET
- Short title
- A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-06-30
- First posted
- 2022-01-12
- Registry last updated
- 2023-02-23
- Primary completion date
- 2023-03-30
- Start date
- 2021-12-09
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05188417
- ClinicalTrials.gov ID
- NCT05188417
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration
Timeframe: 48 hours after the start of administration
The incidence of intracranial hemorrhage (Heidelberg bleeding classification) within 48 hours after the start of administration
Timeframe: 48 hours after the start of administration
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
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
The incidence of moderate bleeding (GUSTO defined) within 48 hours after the start of administration
Timeframe: 48 hours after the start of administration
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
All-cause mortality 90 days after the start of administration
Timeframe: 90 days after the start of administration
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
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
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
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
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
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
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
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)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
- ≥ 18 years of age, regardless of gender;
- 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;
- Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;
- NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;
- Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1 point);
- The subject or his/her guardian participates voluntarily and signs the ICF.
- Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);
- 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);
- Significant head trauma or stroke within 3 months prior to screening;
- Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);
- Previous intracranial tumor, arteriovenous malformation or aneurysm;
- Intracranial or spinal surgery and biopsy within 3 months prior to screening;
- 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);
- Presence of active internal hemorrhage (e.g., gastrointestinal, urinary tract or retinal hemorrhage, etc.);
- 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;
- Hypertension is not controlled after active antihypertensive therapy: systolic blood pressure is ≥ 180 mmHg or diastolic blood pressure is ≥ 100 mmHg;
- Blood glucose concentration is < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
- Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
- Serious renal insufficiency (creatinine clearance rate is < 30 mL/min);
- Currently undergoing renal dialysis;
- Aortic dissection;
- Major surgery or serious trauma within 30 days prior to screening;
- Gastrointestinal or urethral hemorrhage within 30 days prior to screening;
- History of acute myocardial infarction within 3 months prior to screening;
- It is known at the time of screening that subjects plan to undergo coronary, carotid or peripheral arterial revascularization during the trial;
- 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;
- Users who are known to be allergic or contraindicated to the investigational product;
- Life expectancy of < 6 months due to any advanced disease;
- Patients who have participated in drug or device trials within one month;
- Patients with poor peripheral venous filling who cannot establish two standard peripheral venous lines;
- Stroke accompanied by seizures;
- 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.
- 23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou DistrictWuhan, China
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Ischemic stroke Primary condition