Uninterrupted Direct-acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures (DOAC-NOSTOP)

La Fe University and Polytechnic Hospital

Status and phase: Enrolling; Phase 4

Conditions: Coronary Artery Disease; Direct Acting Anticoagulant Adverse Reaction; Bleeding

Treatments: Drug: Direct-acting oral anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05292846

515

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Uninterruped direct-acting oral anticoagulation

Experimental group

Description:

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

Treatment:

Drug: Direct-acting oral anticoagulation