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

NCT ID: NCT03252626

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Alprostadil

Based on the standard medical care, 2ml of Alprostadil

Group Type: ACTIVE_COMPARATOR

Alprostadil

Intervention Type: 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.

Normal saline

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SEAAIS

Identifier Type: -

Identifier Source: org_study_id