Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01828697 · ClinicalTrials.gov registry record · Phase 4

Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

A Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Completed
Registry status
Phase 4
Development phase
1,110
Enrollment target
20
Study locations

NCT01828697 is a Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis that has completed, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The registered enrollment target is 1,110 participants, below the 3,035-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 2 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01828697, a Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis, has completed, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

COMPLETED
Registry status
Phase 4
Development phase
1,110 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.

Interventions

  • DRUG Low dose nadroparin
  • DRUG Intermediate dose nadroparin
  • DRUG Low dose enoxaparin
  • DRUG Intermediate dose enoxaparin
  • DRUG Low dose dalteparin

Study Locations (20)

Other

  • KU Leuven - Leuven
  • The Ottawa Hospital - Ottawa
  • Aalborg University Hospital - Aalborg
  • Aarhus University Hospital - Aarhus
  • CHU de Besancon - Besançon
  • CHU de Bordeaux - Bordeaux
  • CHU de Brest - Brest
  • CHU de Caen - Caen
  • CHU de Clermont - Ferrand - Clermont-Ferrand
  • APHP Louis Mourier - Colombes
  • CHU de Grenoble - Grenoble
  • CHU de Limoges - Limoges
  • Hopiteaux de Marseille - Marseille
  • Marseille St Joseph - Marseille
  • CHU de Nancy - Nancy
  • CHU de Nice - Nice
  • CHU de Nîmes - Nîmes
  • APHP Antoine Béclère - Paris
  • APHP Port Royal - Paris

New York

  • Weill Cornell Medicine | NewYork-Presbyterian - New York

Trial Details

FieldValue
Enrollment Target 1,110 participants
Start Date 2013-04-24
Est. Completion 2021-10-31
Phase Phase 4

What the Registry Record Tells You About NCT01828697

The ClinicalTrials.gov registry entry for NCT01828697 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,035-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (63% lower). The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pulmonary Embolism appearing as the primary indexed condition, and to 5 interventions - of which Low dose nadroparin is the first listed.

NCT01828697 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New York.

Frequently Asked Questions

What is clinical trial NCT01828697 about?

NCT01828697 is a clinical study titled "Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy". This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACC...

What is the current status of trial NCT01828697?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,110 participants. The study started on 2013-04-24. Estimated completion is 2021-10-31.

What conditions does trial NCT01828697 study?

This clinical trial studies the following conditions: Pulmonary Embolism, Deep Venous Thrombosis.

What interventions are being tested in trial NCT01828697?

The interventions under investigation include: Low dose nadroparin (DRUG), Intermediate dose nadroparin (DRUG), Low dose enoxaparin (DRUG), Intermediate dose enoxaparin (DRUG), Low dose dalteparin (DRUG).

Who is sponsoring clinical trial NCT01828697?

This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01828697 being conducted?

This trial has 20 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pulmonary Embolism

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.