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Anticoagulant

On-X valve using reduced anticoagulation for Valvular Heart Disease (PROACT Trial)

N/A

Waitlist Available

Research Sponsored by On-X Life Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years

Awards & highlights

PROACT Trial Summary

This trial shows that various patient groups with the On-X Valve can be safely maintained on lower doses of blood thinner or on antiplatelet drugs.

Eligible Conditions

Valvular Heart Disease

PROACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bleeding Events

Thromboembolism

Valve Thrombosis

Secondary outcome measures

New York Heart Association (NYHA) classification

Valve Hemodynamics

Valve-Related Events

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Late RT Toxicity: Other: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Nausea

Hyperglycemia NOS

Depression NEC

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Stomatitis

Platelet count decreased

Blood albumin decreased

Weight decreased

Anorexia

Hypocalcemia

Hyponatremia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

PROACT Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: MVR with lower warfarinExperimental Treatment1 Intervention

MVR with lower warfarin

Group II: AVR Low Risk without warfarinExperimental Treatment1 Intervention

AVR Low Risk without warfarin

Group III: AVR High risk with lower warfarinExperimental Treatment1 Intervention

AVR High risk with lower warfarin

Group IV: AVR low risk with standard warfarinActive Control1 Intervention

AVR low risk with standard warfarin

Group V: AVR High Risk with standard warfarinActive Control1 Intervention

AVR High Risk with standard warfarin

Group VI: MVR with standard warfarinActive Control1 Intervention

MVR with standard warfarin

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

On-X Life Technologies, Inc.Lead Sponsor

3 Previous Clinical Trials

1,387 Total Patients Enrolled

2 Trials studying Valvular Heart Disease

877 Patients Enrolled for Valvular Heart Disease

Clinipace WorldwideIndustry Sponsor

14 Previous Clinical Trials

2,140 Total Patients Enrolled

Acelis Connected HealthUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility requirements for registering in this clinical experiment?

"Aspiring candidates that wish to enrol in this clinical trial must present with valvular heart disease, and be between 18-70 years of age. The scope of the study contains 1200 participants."

Answered by AI

What is the geographical scope of this scientific experiment?

"Swedish Medical Center in Seattle, University Hospital - Cleveland in Ohio and Florida Hospital in Orlando are just a few of the 50 sites running this clinical study."

Answered by AI

Does this study cater to participants of an advanced age?

"This medical study only allows participants aged between 18 and 70 to participate. If a patient is younger than 18 or older than 65, they may qualify for one of the two trials catered towards those cohorts."

Answered by AI

Is enrollment currently available for this study?

"As per the information on clinicaltrials.gov, this experiment has concluded its recruitment phase - it was originally posted in June 2006, and last updated 13th September 2022. Currently, there are 52 other medical trials that require more participants."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Anticoagulation and Antiplatelet Strategies After On-x Mechanical Aortic Valve Replacement

Puskas, John D., Marc Gerdisch, Dennis Nichols, Lilibeth Fermin, Birger Rhenman, Divya Kapoor, Jack Copeland, et al.. 2018. “Anticoagulation and Antiplatelet Strategies After On-x Mechanical Aortic Valve Replacement”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2018.03.535.

Journal of the American College of CardiologyJournal

Puskas, John D.. 2018. “Reply”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2018.07.063.

Current Opinion in CardiologyJournal

Reduced Anticoagulation Is Safe in High-risk Patients with the On-x Mechanical Aortic Valve

Yanagawa, Bobby, Sidney Levitsky, and John D. Puskas. 2015. “Reduced Anticoagulation Is Safe in High-risk Patients with the On-x Mechanical Aortic Valve”. Current Opinion in Cardiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/hco.0000000000000149.

The Journal of Thoracic and Cardiovascular SurgeryJournal

Reduced Anticoagulation After Mechanical Aortic Valve Replacement: Interim Results from the Prospective Randomized On-x Valve Anticoagulation Clinical Trial Randomized Food and Drug Administration Investigational Device Exemption Trial