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

NCT05188417 | Unknown Phase 2 DMC

• 1 other identifier: GPTF0201
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Tirofiban

Outcome Measures

Primary Outcomes (1)

• The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration

  48 hours after the start of administration

Secondary Outcomes (14)

• The incidence of intracranial hemorrhage (Heidelberg bleeding classification) within 48 hours after the start of administration

  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

  48 hours after the start of administration

• The incidence of parenchymal hemorrhage type 2 (PH-2) within 48 hours after the start of administration

  48 hours after the start of administration

• The incidence of moderate bleeding (GUSTO defined) within 48 hours after the start of administration

  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.)

  90 days after the start of administration

Study Arms (3)

Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group

EXPERIMENTAL

The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.25μg/kg/min (0.005 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours.

Drug: Tirofiban 0.05 MG/ML

Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group

EXPERIMENTAL

The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.4 μg/kg/min (0.008 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours.

Drug: Tirofiban 0.05 MG/ML

0.9% sodium chloride solution

PLACEBO COMPARATOR

The placebo is pumped intravenously at a constant rate of 0.008 ml/kg/min for 30 minutes, and then pumped intravenously at a constant rate of 0.002 ml/kg/min for 24 hours.

Drug: 0.9% sodium chloride solution

Interventions

Tirofiban 0.05 MG/ML DRUG

intravenous injection of the drug according to different body weights and arms

Also known as: Alteplase

Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group; Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group

0.9% sodium chloride solution DRUG

intravenous injection of the drug according to different body weights and arms

Also known as: Alteplase

0.9% sodium chloride solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• GrandPharma (China) Co., Ltd.: lead

Study Sites (1)

23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou District

Wuhan, Hubei, 430032, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tirofiban; Tissue Plasminogen Activator; Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhipeng Wang, Ph.D, MD

  GrandPharma (China) Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 12, 2022
• Study Start: December 9, 2021
• Primary Completion: March 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)