AzTrials
AzTrials

Coronary Artery DiseasePhase 4DOAC-NOSTOPNCT05292846

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

A Phase 4 study testing Direct-acting oral anticoagulation in people with Coronary Artery Disease and Bleeding, run by Hospital Universitario La Fe at 4 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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). Read more about this study

Who is it for?
Any age
What is being tested?
Direct-acting oral anticoagulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesin 2 countries
Study dates
20 Jan 2022to 20 Apr 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

4 sites in 2 countries.

Jorge Sanz Sanchez, MD, PhD contact

440087

sjorge4@gmx.com

4 sites in 2 countries

Spain3 sites, 3 recruiting

  • Hospital del Mar

    Barcelona

    Beatriz Vaquerizo Montilla

    Recruiting

  • Hospital La Paz

    Madrid

    Alfonso Jurado Román

    Recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026

    Jorge Sanz Sanchez, MD, PhD, 440087, sjorge4@gmx.com

    Jose Luis Diez Gil, MD, PhD

    Recruiting

Other trials in Spain

Italy1 site, 1 recruiting

  • Humanitas Research Hospital

    Rozzano, Milan, 20089

    Giulio Stefanini, Prof, 0282247384, giulio.stefanini@gmail.com

    Giulio Stefanini, Prof

    Not yet recruiting

Other trials in Italy

About this study

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.

Read the 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.

Being tested
Direct-acting oral anticoagulation
Medical subject headings
Coronary Artery Disease, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct-acting oral anticoagulationDrug

    Apixaban Dabigatran Edoxaban Rivaroxaban

Study groups in NCT05292846
Study groupRoleWhat they receive
Uninterruped direct-acting oral anticoagulationExperimentalUninterrupted direct-acting oral anticoagulation in patients undergoing trans-radial percutaneous coronary procedures
Receives: Drug: Direct-acting oral anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30-day follow-up

Secondary outcomes (9)

  1. Rate of BARC type 3, or 5

    Measured: 30-day follow-up

  2. Rate of all-cause death

    Measured: 30-day follow-up

  3. Rate of cardiac death

    Measured: 30-day follow-up

  4. Rate of stroke

    Measured: 30-day follow-up

  5. Rate of myocardial infarction

    Measured: 30-day follow-up

  6. Rate of definite/probable stent thrombosis

    Measured: 30-day follow-up

  7. Rate of definite stent thrombosis

    Measured: 30-day follow-up

  8. Rate of target-lesion revascularization

    Measured: 30-day follow-up

  9. Rate of target-vessel revascularization

    Measured: 30-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2022
  2. Study start20 Jan 2022
  3. Primary completion20 Feb 2024 (estimated)
  4. Study completion20 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05292846
Sponsor's protocol ID
515
Acronym
DOAC-NOSTOP
Status last verified
Jan 2024
First submitted
14 Mar 2022
Last updated
26 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data that support the findings of this study will be available from the corresponding author on reasonable request.

Publications

  • 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.

    PubMed 26324049

  • 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.

    PubMed 20062939

  • 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.

    PubMed 32950419

  • 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.

    PubMed 9728982

  • 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.

    PubMed 30052888

  • 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.

    PubMed 40530906

  • Teira Calderon A, Chiarito M, Santos IA, Cao D, Vaquerizo Montilla B, Jurado Roman A, Pulido Garrido P, Tartaglia F, Garcia-Garcia HM, Diez-Gil JL, Sanz-Sanchez J. Uninterrupted direct-acting oral anticoagulation in patients undergoing transradial percutaneous coronary procedures: The DOAC-NOSTOP study rationale and design. Cardiovasc Revasc Med. 2024 Jun;63:68-72. doi: 10.1016/j.carrev.2024.01.013. Epub 2024 Jan 28.

    PubMed 38307792

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Direct-acting oral anticoagulation in people with Coronary Artery Disease and Bleeding, run by Hospital Universitario La Fe at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jorge Sanz Sanchez, MD, PhD (440087, sjorge4@gmx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 (time frame: 30-day follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05292846, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in