Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03252626
• Other study ID #: SEAAIS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 18, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ischemic stroke has a variety of treatments and currently drug therapy is one of the main treatments.A number of clinical studies have proved that alprostadil (PGE1) has pharmacological effects of significant dilation of blood vessels, inhibition of plate aggregation, anti-atherosclerosis and increased cerebral blood flow.Evaluate the 90-days efficacy by comparing two groups of patients'(one with alprostadil,another with placebo) mRS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 950
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. ischemic stroke diagnosed by CT or MRI

2. Age: 18-75 years

3. Pre-stroke mRS score is 0-1

4. within 72 hours symptoms onset

5. 4 = NIHSS <20

6. Patient is willing to participate voluntarily and to sign a written patient informed consent

Exclusion Criteria:

1. intracranial tumors, encephalitis or lesions diagnosed by CT or MRI

2. patients with thrombolytic therapy

3. low platelet , blood system diseases or other bleeding tendency

4. suspected subarachnoid hemorrhage or aortic dissection coma

5. atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate <50 beats / min

6. ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate<30ml/min

7. Dementia and mental illness

8. Patient who is participating in other trials or has been participated in other trials in recent 3 months

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Alprostadil
Alprostadil injection USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1. Vasodilation, inhibition of platelet aggregation are among the most notable of these effects. 2ml Alprostadil injection added into 10ml 0.9% saline.
• Normal saline
2ml normal saline injection added into 10ml 0.9% saline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale at Day 90		day 90
Secondary	Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke	Major adverse vascular events include ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular-related death.	day 30, day 90
Secondary	Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke		day 30, day 90
Secondary	Barthel Index score	compared the changes in activities of daily living (Barthel index) between the two groups	day 30, day 90
Secondary	EQ-5D scale	compared the changes in EQ-5D scale	day 30, day 90
Secondary	Documentation of adverse events (AEs)	compared the rates of adverse events	day 30, day 90