StrokePhase 4NCT03252626
Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
A Phase 4 study testing Alprostadil and Normal saline in people with Stroke, run by The First Hospital of Jilin University.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Alprostadil and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 950 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke diagnosed by CT or MRI
- Age: 18-75 years
- Pre-stroke mRS score is 0-1
- within 72 hours symptoms onset
- 4 ≤ NIHSS <20
- Patient is willing to participate voluntarily and to sign a written patient informed consent
Who cannot join
- 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
About this study
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
- Being tested
- Alprostadil, Normal saline
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprostadilDrug
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 salineDrug
2ml normal saline injection added into 10ml 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| Alprostadil | Active comparator | Based on the standard medical care, 2ml of Alprostadil Receives: Drug: Alprostadil |
| Normal saline | Placebo comparator | Based on the standard medical care, 2ml of 0.9% saline as the placebo Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale at Day 90
Measured: day 90
Secondary outcomes (5)
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.
Measured: day 30, day 90
Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
Measured: day 30, day 90
Barthel Index score
compared the changes in activities of daily living (Barthel index) between the two groups
Measured: day 30, day 90
EQ-5D scale
compared the changes in EQ-5D scale
Measured: day 30, day 90
Documentation of adverse events (AEs)
compared the rates of adverse events
Measured: day 30, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start18 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252626
- Sponsor's protocol ID
- SEAAIS
- Status last verified
- Feb 2024
- First submitted
- 8 Aug 2017
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Alprostadil Injection in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03252626
- Acronym / sponsor ID
- SEAAIS
- Conditions
- Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 18 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil | Active comparator | Drug: AlprostadilBased on the standard medical care, 2ml of Alprostadil |
| Normal saline | Placebo comparator | Drug: Normal salineBased on the standard medical care, 2ml of 0.9% saline as the placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ischemic stroke diagnosed by CT or MRI
- Age: 18-75 years
- Pre-stroke mRS score is 0-1
- within 72 hours symptoms onset
- 4 ≤ NIHSS <20
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprostadilAlprostadil 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. | Drug | Alprostadil |
| Normal saline2ml normal saline injection added into 10ml 0.9% saline. | Drug | Normal saline |
Primary outcome
Modified Rankin Scale at Day 90
Time frame: day 90
5 secondary outcomes
Incidence of major vascular events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
Time frame: day 30, day 90
Incidence of stroke events in 30 or 90 days including ischemic stroke and hemorrhagic stroke
Time frame: day 30, day 90
Barthel Index score
Time frame: day 30, day 90
EQ-5D scale
Time frame: day 30, day 90
Documentation of adverse events (AEs)
Time frame: day 30, day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprostadil and Normal saline in people with Stroke, run by The First Hospital of Jilin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale at Day 90 (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.