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

Coronary Artery Disease Clinical Trial

— DOAC-NOSTOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292846
• Other study ID #: 515
• Status: Recruiting
• Phase: Phase 4
• Start date: January 20, 2022
• Est. completion date: April 20, 2024

Study information

• Verified date: January 2024
• Source: Hospital Universitario La Fe
• Contact: Jorge Sanz Sanchez, MD, PhD
• Phone: 440087
• Email: sjorge4[@]gmx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Coronary Artery Disease

Intervention

Drug:
• Direct-acting oral anticoagulation
Apixaban Dabigatran Edoxaban Rivaroxaban

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan
Spain	Hospital del Mar	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Countries where clinical trial is conducted

Italy,  Spain, 

References & Publications (5)

Kogame N, Guimaraes PO, Modolo R, De Martino F, Tinoco J, Ribeiro EE, Kawashima H, Ono M, Hara H, Wang R, Cavalcante R, Moulin B, Falcao BAA, Leite RS, de Almeida Sampaio FB, Morais GR, Meireles GC, Campos CM, Onuma Y, Serruys PW, Lemos PA. Aspirin-Free P — View Citation

Lip GY, Huber K, Andreotti F, Arnesen H, Airaksinen KJ, Cuisset T, Kirchhof P, Marin F; European Society of Cardiology Working Group on Thrombosis. Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrom — View Citation

Lip GYH, Collet JP, Haude M, Byrne R, Chung EH, Fauchier L, Halvorsen S, Lau D, Lopez-Cabanillas N, Lettino M, Marin F, Obel I, Rubboli A, Storey RF, Valgimigli M, Huber K; ESC Scientific Document Group. 2018 Joint European consensus document on the manag — View Citation

Serruys PW, van Hout B, Bonnier H, Legrand V, Garcia E, Macaya C, Sousa E, van der Giessen W, Colombo A, Seabra-Gomes R, Kiemeneij F, Ruygrok P, Ormiston J, Emanuelsson H, Fajadet J, Haude M, Klugmann S, Morel MA. Randomised comparison of implantation of — View Citation

Valgimigli M, Frigoli E, Leonardi S, Rothenbuhler M, Gagnor A, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Presbitero P, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabate M, Heg D, Juni P, Vranckx P; MATRIX Investigators. Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes. N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5		30-day follow-up
Secondary	Rate of BARC type 3, or 5		30-day follow-up
Secondary	Rate of all-cause death		30-day follow-up
Secondary	Rate of cardiac death		30-day follow-up
Secondary	Rate of stroke		30-day follow-up
Secondary	Rate of myocardial infarction		30-day follow-up
Secondary	Rate of definite/probable stent thrombosis		30-day follow-up
Secondary	Rate of definite stent thrombosis		30-day follow-up
Secondary	Rate of target-lesion revascularization		30-day follow-up
Secondary	Rate of target-vessel revascularization		30-day follow-up