Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism

NCT06393868 | Recruiting Phase 3 DMC

• 1 other identifier: RADIANT-001
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

Brief Summary

The investigators are studying whether treatment with a proton pump inhibitor called omeprazole reduces gastrointestinal bleeding in older adults taking blood thinners for a blood clot (venous thromboembolism). The purpose of this study, a pilot study or a feasibility study, is to test the study plan and determine whether enough participants will join a larger study and accept the study procedures.

Conditions

Venous Thromboembolism; Gastro Intestinal Bleeding; Blood Clot

Keywords

Omeprazole; VTE; GI Bleeding

Outcome Measures

Primary Outcomes (1)

• Study feasibility at participating centres

  The mean number of participants recruited per site per month

  24 months

Secondary Outcomes (4)

• Eligibility Rate

  24 months

• Consent Rate

  24 months

• Retention Rate

  27 months

• Adherence Rate

  27 months

Other Outcomes (17)

• Risk Factors

  24 months

• Patients already prescribed proton pump inhibitor

  24 months

• Reasons for Declining Participation

  24 months

Study Arms (2)

Daily dose of omeprazole 20 mg

EXPERIMENTAL

Participants randomized to the experimental arm will take one omeprazole 20 mg tablet by mouth every day for the duration of their participation in the study.

Drug: Omeprazole 20 mg Oral Tablet

Daily dose of placebo

PLACEBO COMPARATOR

Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.

Other: Placebo

Interventions

Omeprazole 20 mg Oral Tablet DRUG

Omeprazole once daily for 90 days

Also known as: Omeprazole

Daily dose of omeprazole 20 mg

Placebo OTHER

Placebo once daily for 90 days

Daily dose of placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female 65 years or older at the time of enrolment. Enrolment is limited to older adults as age is an important non-modifiable risk factor for bleeding. This will ensure the study population includes participants who may be more likely to benefit from omeprazole (compared to those with no risk factors) because all participants will have at least 1 risk factor for bleeding.
• Newly diagnosed VTE which includes VTE at any site such as (but not limited to) DVT of upper or lower limbs, PE, cerebral vein thrombosis, portal vein thrombosis, other splanchnic vein thrombosis.
• Planned for 3 months (90 days) or more of therapeutic anticoagulation with any anticoagulant.
• Patient or delegate is able and willing to comply with follow-up examinations contained within the consent form.

You may not qualify if:

• Therapeutic anticoagulation therapy for more than 7 days
• Currently prescribed PPI for regular daily use (patients receiving H2 receptor antagonists will not be excluded),
• Previous upper GI bleeding,
• Need for dual antiplatelet therapy,
• Contraindications to omeprazole (hypersensitivity to omeprazole, or other substituted benzimidazole PPIs, concomitant use with products that contain rilpivirine, significant drug interactions, up to the discretion of the site investigator),
• Life expectancy is less than 3 months.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (7)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Niagara Health System - St. Catharines Site

St. Catharines, Ontario, L2S 0A9, Canada

NOT YET RECRUITING

University Health Network - Toronto General

Toronto, Ontario, M5G 2c4, Canada

RECRUITING

CIUSSS de l'Est-de- l'Île-de-Montréal

Montreal, Quebec, H1T2M4, Canada

NOT YET RECRUITING

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

CHU de Québec-Université Laval; Hôpital Saint-François d'Assise

Québec, Quebec, G1R2J6, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, G1V4G5, Canada

RECRUITING

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• Le Gal G, Carrier M, Castellucci LA, Cuker A, Hansen JB, Klok FA, Langlois NJ, Levy JH, Middeldorp S, Righini M, Walters S; ISTH CDE Task Force. Development and implementation of common data elements for venous thromboembolism research: on behalf of SSC Subcommittee on official Communication from the SSC of the ISTH. J Thromb Haemost. 2021 Jan;19(1):297-303. doi: 10.1111/jth.15138.

  PMID: 33405381 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Gastrointestinal Hemorrhage; Thrombosis

Interventions

Omeprazole; Tablets

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Deborah Siegal, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Siegal, MD

CONTACT

(613) 737-8899; dsiegal@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 1, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting after study completion
• Access Criteria: Select members of the International Network of VENous Thromboembolism Clinical Research Networks (INVENT) participating in CONVERGE trials will enter into an agreement to enhance data-sharing and meta-analysis across trials. Access will be restricted by strict authentication processes and data will be maintained on secure servers.

Locations

CA (7)