Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures

NCT ID: NCT05292846

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2024-04-20

Brief Summary

Up to 20-30% of patients who are candidates for direct oral anticoagulation (DOAC) present with concomitant ischemic heart disease and often require coronary angiography with or without percutaneous coronary intervention (PCI). The decision whether to continue the DOAC throughout periprocedural period or interrupt DOAC before planned procedure represents a substantial challenge in daily clinical practice.

The objective of this study is to evaluate the safety of uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures.

Detailed Description

The study design is an investigator-initiated, single-arm, open-label, pilot study in patients treated with DOAC undergoing trans-radial percutaneous coronary procedures.

Because of the exploratory nature of this study, no formal sample size calculations are required. On the basis of previous pilot studies with similar designs, a sample of 200 patients is planned; with a safety stopping rule based on the occurrence of BARC type 3 or 5 bleeding. In the present trial, if during the enrollment period more than 3 cases of BARC 3 or 5 bleeding occur up to 30-day follow-up, patient recruitment will be terminated. This number is based on the reported 1.6% BARC type 3 or 5 bleeding in patients undergoing transradial percutaneous coronary procedures.

Conditions

Coronary Artery Disease; Bleeding; Direct Acting Anticoagulant Adverse Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Uninterruped direct-acting oral anticoagulation

Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures

Group Type: EXPERIMENTAL

Direct-acting oral anticoagulation

Intervention Type: DRUG

Apixaban Dabigatran Edoxaban Rivaroxaban

Interventions

Direct-acting oral anticoagulation

Apixaban Dabigatran Edoxaban Rivaroxaban

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients under anticoagulation with DOAC and any indication for diagnostic or therapeutic trans-radial percutaneous coronary procedures. At least 25% of the population undergoing PCI will be included.

Exclusion Criteria

1. Aged < 18 years

2. Cardiogenic shock

3. Major active bleeding at the time of the procedure

4. Use of mechanical circulatory support

5. Chronic total occlusions

6. Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar)

7. Inability to provide informed consent

8. Unable to understand and follow study-related instructions or unable to comply with study protocol

9. Currently participating in another trial

10. Pregnant women

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Fe

OTHER

Sponsor Role: lead

Responsible Party

Jorge Sanz Sanchez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status: NOT_YET_RECRUITING

Hospital del Mar

Barcelona, , Spain

Site Status: RECRUITING

Hospital La Paz

Madrid, , Spain

Site Status: RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, , Spain

Site Status: RECRUITING

Countries

Italy; Spain

Central Contacts

Jorge Sanz Sanchez, MD, PhD

Role: CONTACT

sjorge4@gmx.com

440087

Facility Contacts

Giulio Stefanini, Prof

Role: primary

giulio.stefanini@gmail.com

0282247384

Beatriz Vaquerizo Montilla

Role: primary

Alfonso Jurado Román

Role: primary

Jorge Sanz Sanchez, MD, PhD

Role: primary

sjorge4@gmx.com

440087

References

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Reference Type: DERIVED

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Other Identifiers

515

Identifier Type: -

Identifier Source: org_study_id