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

NCT03252626 | Not Yet Recruiting Phase 4

• 1 other identifier: SEAAIS
• Study Type: interventional
• Target: 950
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale at Day 90

  day 90

Secondary Outcomes (5)

• Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke

  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

  day 30, day 90

• EQ-5D scale

  day 30, day 90

• Documentation of adverse events (AEs)

  day 30, day 90

Study Arms (2)

Alprostadil

ACTIVE COMPARATOR

Based on the standard medical care, 2ml of Alprostadil

Drug: Alprostadil

Normal saline

PLACEBO COMPARATOR

Based on the standard medical care, 2ml of 0.9% saline as the placebo

Drug: Normal saline

Interventions

Alprostadil DRUG

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.

Alprostadil

Normal saline DRUG

2ml normal saline injection added into 10ml 0.9% saline.

Normal saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ischemic stroke diagnosed by CT or MRI
• Age: 18-75 years
• Pre-stroke mRS score is 0-1
• within 72 hours symptoms onset
• ≤ NIHSS \<20
• Patient is willing to participate voluntarily and to sign a written patient informed consent

You may not qualify if:

• intracranial tumors, encephalitis or lesions diagnosed by CT or MRI
• patients with thrombolytic therapy
• low platelet , blood system diseases or other bleeding tendency
• suspected subarachnoid hemorrhage or aortic dissection coma
• atrial fibrillation, myocardial infarction, heart valve disease, infective endocarditis, heart rate \<50 beats / min
• ALT or AST continued to rise more than 3 times the upper limit of normal creatinine clearance rate\<30ml/min
• Dementia and mental illness
• Patient who is participating in other trials or has been participated in other trials in recent 3 months

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Stroke

Interventions

Alprostadil; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 17, 2017
• Study Start: April 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-02