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

Phase 4

Recruiting

• Conditions: Bleeding; Coronary Artery Disease; Direct Acting Anticoagulant Adverse Reaction
• Interventions: Drug: Direct-acting oral anticoagulation

• Registration Number: NCT05292846
• Lead Sponsor: Hospital Universitario La Fe

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.

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-02-20
• Study Completion: 2024-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Uninterruped direct-acting oral anticoagulation	Direct-acting oral anticoagulation	Uninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures

Primary Outcome Measures

Name	Time	Method
Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5	30-day follow-up

Secondary Outcome Measures

Name	Time	Method
Rate of BARC type 3, or 5	30-day follow-up
Rate of definite/probable stent thrombosis	30-day follow-up
Rate of definite stent thrombosis	30-day follow-up
Rate of all-cause death	30-day follow-up
Rate of cardiac death	30-day follow-up
Rate of stroke	30-day follow-up
Rate of myocardial infarction	30-day follow-up
Rate of target-lesion revascularization	30-day follow-up
Rate of target-vessel revascularization	30-day follow-up

Trial Locations

Locations (4)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain