Prevention of Recurrent Venous Thromboembolism (PREVENT)

NCT00000614 | Completed Phase 3

• 2 other identifiers: 117R01HL057951
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A multicenter randomized, double blind placebo controlled trial to determine the efficacy of long-term, low dose warfarin in the secondary prevention of venous thromboembolism.

Conditions

Cardiovascular Diseases; Heart Diseases; Peripheral Vascular Diseases; Thromboembolism; Vascular Diseases; Venous Thromboembolism

Interventions

warfarin DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Patients with venous thromboembolism, including patients with factor V Leiden. Patients had completed prescribed anticoagulation therapy within the last two years before the trial and were not currently on anticoagulation therapy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (5)

• Ridker PM. Long-term, low-dose warfarin among venous thrombosis patients with and without factor V Leiden mutation: rationale and design for the Prevention of Recurrent Venous Thromboembolism (PREVENT) trial. Vasc Med. 1998;3(1):67-73. doi: 10.1177/1358836X9800300114.

  PMID: 9666536 BACKGROUND

• Ridker PM, Goldhaber SZ, Danielson E, Rosenberg Y, Eby CS, Deitcher SR, Cushman M, Moll S, Kessler CM, Elliott CG, Paulson R, Wong T, Bauer KA, Schwartz BA, Miletich JP, Bounameaux H, Glynn RJ; PREVENT Investigators. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med. 2003 Apr 10;348(15):1425-34. doi: 10.1056/NEJMoa035029. Epub 2003 Feb 24.

  PMID: 12601075 BACKGROUND

• Schafer AI. Warfarin for venous thromboembolism - walking the dosing tightrope. N Engl J Med. 2003 Apr 10;348(15):1478-80. doi: 10.1056/NEJMe030018. Epub 2003 Feb 24. No abstract available.

  PMID: 12601074 BACKGROUND

• Miles JS, Miletich JP, Goldhaber SZ, Hennekens CH, Ridker PM. G20210A mutation in the prothrombin gene and the risk of recurrent venous thromboembolism. J Am Coll Cardiol. 2001 Jan;37(1):215-8. doi: 10.1016/s0735-1097(00)01080-9.

  PMID: 11153741 BACKGROUND

• Sick PB, Brosteanu O, Ulrich M, Thiele H, Niebauer J, Busch I, Schuler G. Prospective randomized comparison of early and late results of a carbonized stent versus a high-grade stainless steel stent of identical design: the PREVENT Trial [corrected]. Am Heart J. 2005 Apr;149(4):681-8. doi: 10.1016/j.ahj.2004.07.011.

  PMID: 15990753 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Peripheral Vascular Diseases; Thromboembolism; Vascular Diseases; Venous Thromboembolism

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Robert Glynn

  Brigham and Women's Hospital

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1998
• Study Completion: August 1, 2004
• Last Updated: March 16, 2016

Record last verified: 2005-09