Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy
This study has been completed.
Sponsor:
Yasser Elnahas
Information provided by (Responsible Party):
Yasser Elnahas, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01758640
First received: December 25, 2012
Last updated: January 25, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A prospective, randomized, longitudinal, open label, parallel group clinical trial was designed to compare the proportions of failure to reach INR target 2.5-3.5 with either: small dose warfarin (<5 mg/day) or phenindione (<100 mg/day), in high-risk pregnant and non-pregnant patients with bileaflet mechanical heart valve prosthesis.
| Condition | Intervention | Phase |
|---|---|---|
|
Anticoagulation in Pregnancy |
Drug: Warfarin Drug: phenindione |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety And Efficacy of Low Dose Oral Anticoagulants And Aspirin Therapy Throughout Pregnancy In Patients With Mechanical Heart Valves Prosthesis |
Resource links provided by NLM:
Further study details as provided by Ain Shams University:
Primary Outcome Measures:
- proportions of failure to reach target INR (2.5-3.5) with a maximum daily dose of 5mg warfarin or 100 mg phenindione [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]Low dose warfarin is recommended for pregnant patients with mechanical heart valves to avoid drug related congenital anomalies. The aim of our study is to question if this low dose can achieve target INR in high risk patients with mechanical heart valves implanted in mitral +/- aortic position.
Secondary Outcome Measures:
- Proportions of adverse patients (maternal) outcomes [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]Maternal mortality and anticoagulant related bleeding and thromboembolic events
- Proportions of adverse fetal outcomes [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]Proportions of spontaneous abortions, fetal congenital malformations, prematurity, sill birth, neonatal death and total feta wastage.
- INR achieved with a maximum dose of 5mg warfarin or 100 mg phenindione [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Daily dose of oral anticoagulant in pregnant and non pregnant patients [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
| Enrollment: | 200 |
| Study Start Date: | February 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Pregnant
Group of Pregnant patients who will receive either warfarin or phenindione according to the study design
|
Drug: Warfarin
Low dose warfarin of 5mg or less per day
Drug: phenindione
Phenindione of 100mg or less per day
|
|
Active Comparator: Non Pregnant
Group Of Non Pregnant patients who will receive either warfarin or phenindione according to the study design
|
Drug: Warfarin
Low dose warfarin of 5mg or less per day
Drug: phenindione
Phenindione of 100mg or less per day
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Regular menstrual cycles and no history of congenital malformation, repeated abortions or still birth.
- Patients in NYHA class I or II c) regular INR records for the last 3 months, with the target INR being achieved with warfarin not exceeding 10 mg/day.
- Patient accepting to participate in the study
- Getting pregnant for Group A patients
Exclusion Criteria:
- Patients were excluded from either groups if they refuse to participate in the study or to sign the informed consent.
- Pregnant patients were excluded from Group A if reporting their missed menstrual period or positive pregnancy test later than the 6th week of gestation.
- Patients were excluded from Group B whenever they get pregnant.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758640
Locations
| Egypt | |
| Ain shams University Hospitals | |
| Cairo, Egypt | |
Sponsors and Collaborators
Yasser Elnahas
Investigators
| Study Director: | Ahmed A Hassouna, M.D | Ain Shams University, Cairo Egypr |
| Principal Investigator: | Yasser M Elnahas, M.D. | Ain Shams University |
| Principal Investigator: | Ahmed M Toema, M.SC. | Ain Shams University |
| Principal Investigator: | ayman Ammar, M.D | Ain Shams University |
More Information
Publications:
| Responsible Party: | Yasser Elnahas, M.D, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT01758640 History of Changes |
| Other Study ID Numbers: | AINSHAMS2012 |
| Study First Received: | December 25, 2012 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Egypt: Ministry of Higher Education |
Keywords provided by Ain Shams University:
|
mechanical heart valve pregnancy warfarin phenindione |
Additional relevant MeSH terms:
|
Anticoagulants Phenindione Warfarin |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013