Efficacy of Aspirin and L-arginine in High Risk Preeclamptic

NCT02838030 | Suspended Phase 2 DMC

• 1 other identifier: ECAALA
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Worldwide, the incidence of preeclampsia ranges from 2 to 10% of pregnancies. The World Health Organization (WHO) estimates that the incidence of preeclampsia is seven times higher in developing countries than in developed (2.8% and 0.4%). In Mexico it is estimated that preeclampsia - eclampsia is a major cause of maternal and perinatal morbidity and mortality. Because it is an idiopathic heterogeneous syndrome associated with endothelial damage, so far there is no effective treatment to decrease the morbidity and mortality of this entity, so it is necessary to strengthen prevention; the use of aspirin alone is inconclusive, in addition to the information the investigators have reduced the effect of these strategies on arterial stiffness; Moreover, it has been observed that L-arginine lowers blood pressure in this population. It is for this that is of interest to know the efficacy and safety of the combination of L-arginine low dose, which is known as an important eNOS in NO production substrate, and aspirin for its qualities of antiinflammatory and anticoagulant in the prevention of preeclampsia and also determine their effect on arterial stiffness as a noninvasive method, as is the applanation tonometry.

Conditions

High Risk Pregnancy

Keywords

Preeclampsia; L-arginine

Outcome Measures

Primary Outcomes (2)

• Incidence of preeclampsia

  from 20 weeks gestation until 37 weeks

• severity of preeclampsia

  from 20 weeks gestation until 37 weeks

Secondary Outcomes (16)

• Pulmonary edema maternal

  at week 37

• Acute myocardial infarction maternal

  at week 37

• Stroke maternal

  at week 37

• Acute respiratory distress syndrome maternal

  at week 37

• Coagulopathy maternal

  at week 37

Study Arms (2)

acetylsalicylic acid and L-arginine

EXPERIMENTAL

acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and L-arginine 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination

Drug: L-arginine; Drug: acetylsalicylic acid

acetylsalicylic acid and placebo

PLACEBO COMPARATOR

acetylsalicylic acid 75 mg every 24 hours from the 12th week of pregnancy and placebo 3 gr every 8 hours from the 20th week of pregnancy to pregnancy termination

Drug: Placebo (for L-arginine); Drug: acetylsalicylic acid

Interventions

L-arginine DRUG

3 gr per day

Also known as: arginine

acetylsalicylic acid and L-arginine

Placebo (for L-arginine) DRUG

3 gr per day

Also known as: Magnesia calcined

acetylsalicylic acid and placebo

acetylsalicylic acid DRUG

3 gr per day

Also known as: aspirin

acetylsalicylic acid and L-arginine; acetylsalicylic acid and placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant before 12 weeks of gestation
• High risk of preeclampsia
• Signature of informed consent in writing

You may not qualify if:

• Noncompliance \> 20% of drug intake
• Lack of tolerability L-arginine or acetylsalicylic acid
• Serious adverse event
• Withdrawal of consent

Sponsors & Collaborators

• University of Guadalajara: lead
• PhD Ernesto Javier Ramírez Lizardo: collaborator
• PhD Sylvia Elena Totsuka Sutto: collaborator
• PhD Fernando Grover Páez: collaborator
• MD Diego Hernández Molina: collaborator

Study Sites (1)

Antiguo Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Arginine; Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Leonel García Benavides, PhD

  University Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: July 20, 2016
• Study Start: July 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)