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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Drug: Alprostadil; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Estimated): 950
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alprostadil; Based on the standard medical care, 2ml of Alprostadil	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.
Placebo Comparator: Normal saline; Based on the standard medical care, 2ml of 0.9% saline as the placebo	Drug: Normal saline; 2ml normal saline injection added into 10ml 0.9% saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified Rankin Scale at Day 90	day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke		day 30, day 90
Barthel Index score	compared the changes in activities of daily living (Barthel index) between the two groups	day 30, day 90
EQ-5D scale	compared the changes in EQ-5D scale	day 30, day 90
Documentation of adverse events (AEs)	compared the rates of adverse events	day 30, day 90

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: SEAAIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No