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Nonsteroidal Anti-inflammatory Drug
Aspirin for Pre-eclampsia (ASPERIN Trial)
Phase 2
Recruiting
Led By John M O'Brien, MD
Research Sponsored by John O'Brien, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three times between 11 and 32 weeks of gestation
Awards & highlights
ASPERIN Trial Summary
This trial will help determine if Aspirin has a dose-dependent response in reducing adverse outcomes related to preeclampsia.
Eligible Conditions
- Pre-eclampsia
ASPERIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three times between 11 and 32 weeks of gestation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three times between 11 and 32 weeks of gestation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pulsatility Index (PI)
Secondary outcome measures
Change in CRP levels over time
Change in IL-6 over time
Change in PIGF levels over time
+5 moreASPERIN Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Acetylsalicylic Acid 81mgExperimental Treatment1 Intervention
Patients will receive low dose (81mg) acetylsalicylic acid (Aspirin).
Group II: Acetylsalicylic Acid 162mgExperimental Treatment1 Intervention
Patients will receive low dose (162mg) acetylsalicylic acid (Aspirin).
Group III: Control GroupActive Control1 Intervention
Patients will receive standard of care.
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Who is running the clinical trial?
John O'Brien, MDLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
John M O'Brien, MDPrincipal InvestigatorUniversity of Kentucky
Katherine Vignes, MDStudy ChairUniversity of Kentucky
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Requirements for being included in the control group of the study.You have an autoimmune disease.You have had a type of high blood pressure called "preterm preeclampsia" during a previous pregnancy.You have long-term high blood pressure.You have kidney problems.You do not have any conditions that increase your risk of developing preeclampsia.You have pre-eclampsia and meet the requirements to be part of the study.You have either Type 1 or Type 2 diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Acetylsalicylic Acid 81mg
- Group 2: Acetylsalicylic Acid 162mg
- Group 3: Control Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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