Aspirin to Prevent Preeclampsia in Women With Elevated Blood Pressure and Stage 1 Hypertension (ASPPIRE)

NCT04402385 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2000028023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if low dose aspirin reduces the incidence of hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, eclampsia, and HELLP syndrome) in pregnant women with stage 1 hypertension and elevated blood pressure.

Conditions

Pre-Eclampsia; Stage 1 Hypertension; Elevated Blood Pressure

Keywords

Aspirin

Outcome Measures

Primary Outcomes (1)

• Development of Hypertensive Disorder

  This measure is operationally defined as a yes/no response to the development of any hypertensive disorder of pregnancy (gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome). This is defined by American College of Obstetricians and Gynecologists diagnostic criteria.

  after 20 weeks gestation until 6 weeks postpartum

Secondary Outcomes (14)

• Development of Gestational Hypertension

  after 20 weeks gestation until 6 weeks postpartum

• Development of Preeclampsia

  after 20 weeks gestation until 6 weeks postpartum

• Development of Preeclampsia- 37 Weeks

  up to 37 weeks gestation

• Development of Preeclampsia- 34 Weeks

  up to 34 weeks gestation

• Development of Eclampsia

  after 20 weeks gestation until 6 weeks postpartum

Study Arms (2)

Aspirin

EXPERIMENTAL

Participants randomized to 81 mg of Aspirin daily

Drug: Aspirin 81 mg

Placebo

PLACEBO COMPARATOR

Participants randomized to placebo daily

Drug: Placebo

Interventions

Aspirin 81 mg DRUG

Participants randomized to 81 mg of Aspirin daily

Aspirin

Placebo DRUG

Participants randomized to placebo daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Singleton pregnancy
• Elevated blood pressure (At least 2 systolic BP 120-129 mm Hg within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters) or Stage 1 hypertension (At least 2 systolic BP 130-139 and/or diastolic BP 80-89 within 1 year pre-pregnancy until 20 weeks gestational age on at least 2 separate healthcare encounters)
• Speaks English or Spanish
• Informed and written consent
• Confirmed single live intrauterine pregnancy (confirmed by positive cardiac motion by transvaginal or transabdominal ultrasound)

You may not qualify if:

• Chronic hypertension
• Pre-gestational diabetes
• Chronic renal disease
• \- diagnosis of stage 1 chronic kidney disease or higher and/or GFR \<60 mL/min with duration at least 3 months and/or history of kidney transplantation and/or undergoing peritoneal or hemodialysis
• Systemic lupus erythematous
• Antiphospholipid antibody syndrome (diagnosis made by having 1 or more clinical criteria and 1 or more laboratory criteria)
• Clinical criteria: venous thrombosis, arterial thrombosis, obstetric complications (3 or more unexplained consecutive spontaneous abortions \<10 weeks gestation, 1 or more unexplained deaths of a morphologically normal fetus after 10 weeks gestation, 1 or more premature births before 34 weeks gestation attributable to placental insufficiency, including severe preeclampsia or fetal growth restriction)
• Laboratory criteria: lupus anticoagulant, anti-cardiolipin IgG or IgM with titer \>99th percentile, anti-beta 2 glycoprotein IgG or IgM with titer \>99th percentile. Laboratory result must be positive twice at least 12 weeks apart
• Multifetal gestation
• weeks gestation at time of randomization based on American College of Obstetricians and Gynecologists dating criteria. Dating will be based on last menstrual period (LMP) if regular, sure LMP is available that agrees with ultrasound dating. Otherwise, earliest ultrasound will be used for dating purposes.
• Prior history of hypertensive disorder of pregnancy
• Current pregnancy with known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy
• Women with contraindications to taking aspirin (bleeding diathesis such as Von Willebrand's disease, peptic ulcer disease, aspirin hypersensitivity, nasal polyps, asthma with aspirin-induced bronchospasm, severe liver disease).
• Concurrent participation in another study that influences risk of preeclampsia
• Women who do not plan to deliver within the YNHH system

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Olga Grechukhina, MD: Assistant Professor of Obstetrics, Gynecology & Reproductive Sciences
• Organization: Yale School of Medicine

olga.grechukhina@yale.edu

(203) 785-3091

Study Officials

• Olga Grechukhina, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Hillart Hosier, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: August 6, 2020
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2023-06

Locations

US (1)