NCT05292846

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2022

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

March 14, 2022

Last Update Submit

January 24, 2024

Conditions

Coronary Artery DiseaseBleedingDirect Acting Anticoagulant Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5

    30-day follow-up

Secondary Outcomes (9)

  • Rate of BARC type 3, or 5

    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

  • +4 more secondary outcomes

Study Arms (1)

Uninterruped direct-acting oral anticoagulation

EXPERIMENTAL

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

Drug: Direct-acting oral anticoagulation

Interventions

Direct-acting oral anticoagulationDRUG

Apixaban Dabigatran Edoxaban Rivaroxaban

Uninterruped direct-acting oral anticoagulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Aged \< 18 years
  • Cardiogenic shock
  • Major active bleeding at the time of the procedure
  • Use of mechanical circulatory support
  • Chronic total occlusions
  • Pre-planned vascular access different from radial artery access (i.e. femoral, brachial, ulnar)
  • Inability to provide informed consent
  • Unable to understand and follow study-related instructions or unable to comply with study protocol
  • Currently participating in another trial
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

NOT YET RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital La Paz

Madrid, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26324049BACKGROUND

  • 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 syndrome and/or undergoing percutaneous coronary intervention/ stenting. Thromb Haemost. 2010 Jan;103(1):13-28. doi: 10.1160/TH09-08-0580. Epub 2009 Sep 30.

    PMID: 20062939RESULT

  • 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 Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study. JACC Cardiovasc Interv. 2020 Oct 12;13(19):2251-2262. doi: 10.1016/j.jcin.2020.06.023. Epub 2020 Sep 16.

    PMID: 32950419RESULT

  • 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 heparin-coated stents with balloon angioplasty in selected patients with coronary artery disease (Benestent II). Lancet. 1998 Aug 29;352(9129):673-81. doi: 10.1016/s0140-6736(97)11128-x.

    PMID: 9728982RESULT

  • 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 management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous cardiovascular interventions: a joint consensus document of the European Heart Rhythm Association (EHRA), European Society of Cardiology Working Group on Thrombosis, European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), Latin America Heart Rhythm Society (LAHRS), and Cardiac Arrhythmia Society of Southern Africa (CASSA). Europace. 2019 Feb 1;21(2):192-193. doi: 10.1093/europace/euy174.

    PMID: 30052888RESULT

  • Sanz-Sanchez J, Chiarito M, Calderon AT, Santos IA, Cao D, Jurado-Roman A, Montilla BV, Tartaglia F, Garrido PP, Nardin M, Romero JS, Vallinas-Hernandez S, Marquez DT, Carrasco-Moraleja M, Reimers B, Dolz LM, Diez-Gil JL, Stefanini G, Garcia-Garcia HM. Uninterrupted Direct-Acting Oral Anticoagulation in Patients Undergoing Transradial Percutaneous Coronary Procedures: The DOAC-NOSTOP. Catheter Cardiovasc Interv. 2025 Aug;106(2):1371-1377. doi: 10.1002/ccd.31691. Epub 2025 Jun 18.

    PMID: 40530906DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseHemorrhage

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jorge Sanz Sanchez, MD, PhD

CONTACT

440087sjorge4@gmx.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

January 20, 2022

Primary Completion

February 20, 2024

Study Completion

April 20, 2024

Last Updated

January 26, 2024

Record last verified: 2024-01

Locations

IT(1)ES(3)