Antithrombotic Therapy in Acute Coronary Syndromes and Coronary Artery Ectasia

NCT05233124 | Unknown Phase 2

• 1 other identifier: 21-1248
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The optimal anti-thrombotic therapy to prevent recurrent ischemic events in patients with acute coronary syndrome and coronary artery ectasia (CAE) remains unclear. OVER-TIME is an investigator initiated, exploratory, open label, single center, randomized clinical trial comparing dual antiplatelet therapy (acetyl-salicylic acid plus a P2Y12 inhibitor) with the combination of an antiplatelet monotherapy (a P2Y12 inhibitor) plus a low dose anticoagulant (rivaroxaban, 15mg oral dose) for the prevention of recurrent ischemic events among patients with CAE. The investigators aim to enroll 60 patients with CAE and acute coronary syndromes. After recruitment, patients are randomized to (a) standard of care (dual antiplatelet regimen) or (b) the combination of antiplatelet monotherapy and low dose anticoagulant. Patients will be followed for at least 12 months. The OVER-TIME study aims to assess the efficacy of the regimen in prevention of major cardiovascular events and its security in bleeding events in acute coronary syndromes among patients with CAE. OVER-TIME is the first randomized controlled trial to assess different antithrombotic strategies in patients with CAE and acute coronary syndrome, and its results will offer preliminary data for the prevention of major cardiovascular events and bleeding events in this group of patients.

Conditions

Acute Coronary Syndrome; Coronary Artery Ectasia

Keywords

Coronary artery ectasia; Antithrombotic therapy; Acute coronary syndrome; Coronary dilatation

Outcome Measures

Primary Outcomes (2)

• Composite of cardiovascular death, recurrent MI and repeated revascularization

  Main efficacy combined outcome of cardiovascular death, recurrent MI and repeated revascularization

  1 year.

• Composite of minor and major bleeding events.

  Main safety combined outcome of minor and major events, measured by BARC scale.

  1 year

Secondary Outcomes (2)

• Net clinical benefit composite endpoint, including cardiovascular death, recurrent MI, repeated revascularization and minor/major bleeding

  1 year

• Clot lysis time by turbidimetry

  6 months

Study Arms (2)

Dual antiplatelet therapy

ACTIVE COMPARATOR

Acetyl salicylic acid, 100mg once a day + clopidogrel 75mg, once a day.

Drug: Acetylsalicylic acid 100mg; Drug: Clopidogrel 75 Mg Oral Tablet

Antiplatelet monotherapy + low dose anticoagulant

EXPERIMENTAL

Clopidogrel 75mg + Rivaroxaban 75mg

Drug: Rivaroxaban 15 MG; Drug: Clopidogrel 75 Mg Oral Tablet

Interventions

Rivaroxaban 15 MG DRUG

Rivaroxaban 15mg

Also known as: Clopidogrel 75mg

Antiplatelet monotherapy + low dose anticoagulant

Acetylsalicylic acid 100mg DRUG

Acetylsalicylic acid 100mg

Also known as: Aspirin

Dual antiplatelet therapy

Clopidogrel 75 Mg Oral Tablet DRUG

Clopidogrel 75mg

Also known as: Plavix

Antiplatelet monotherapy + low dose anticoagulant; Dual antiplatelet therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities.
• Hospitalized male or female aged \>18 years.
• First event of ACS (including both, ST- Segment Elevation or Non- ST Elevation Myocardial Infarction) with high sensitivity troponin T levels exceeding 99th percentile or segmental motion abnormalities by echocardiography.
• Angiographic evidence of CAE involving the infarction culprit artery.
• Hospital length of stay \>24 hours.
• Percutaneous revascularization or medical treatment according to the treating physician criteria.

You may not qualify if:

• Indication for temporary or permanent anticoagulation.
• Relative or absolute contraindications to receive anticoagulation.
• Chronic kidney disease (CKD) KDIGO \> III or GFR \<30 ml/min/1.73 m2
• Angiographic evidence of coronary aneurysms (saccular or fusiform)
• Patients undergoing coronary artery bypass graft (CABG).
• Left ventricular ejection fraction \<40%.
• History of major bleeding events.
• Pregnant women.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (2)

Instituto Nacional de Cardiologia

Mexico City, 14030, Mexico

RECRUITING

Instituto Nacional de Cardiología "Ignacio Chavez"

Mexico City, 14030, Mexico

RECRUITING

Related Publications (2)

• Araiza-Garaygordobil D, Gopar-Nieto R, Sierra-Lara Martinez JD, Mullasari AS, Belderrain-Morales N, Najera-Rojas NA, Diaz-Herrera BA, Sarabia-Chao V, Alfaro-Ponce DL, Briseno-De la Cruz JL, Ruiz-Beltran M, Martinez-Rios MA, Pina-Reyna Y, Latapi-Ruiz Esparza X, Grimaldo-Gomez FA, Cortina-De la Rosa E, Romero-Arroyo MO, Sierra-Gonzalez de Cossio A, Gonzalez-Pacheco H, Arias-Mendoza A. A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia. Am Heart J. 2025 Mar;281:103-111. doi: 10.1016/j.ahj.2024.11.012. Epub 2024 Nov 29.

  PMID: 39615618 DERIVED

• Araiza-Garaygordobil D, Gopar-Nieto R, Sierra-Lara Martinez D, Belderrain-Morales N, Sarabia-Chao V, Alfaro-Ponce DL, Ontiveros-Mercado H, Mendoza-Garcia S, Altamirano-Castillo A, Martinez-Amezcua P, Cabello-Lopez A, Briseno-De la Cruz JL, Ruiz-Beltran M, Martinez-Rios MA, Pina-Reyna Y, Gonzalez-Pacheco H, Arias-Mendoza A. Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Oral Anticoagulation in Patients with Acute Coronary Syndrome and Coronary Artery Ectasia: Design and Rationale of OVER-TIME Randomized Clinical Trial. High Blood Press Cardiovasc Prev. 2022 Sep;29(5):463-468. doi: 10.1007/s40292-022-00535-4. Epub 2022 Jul 29.

  PMID: 35904750 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Aneurysm

Interventions

Rivaroxaban; Clopidogrel; Aspirin; Tablets

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Aneurysm

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Diego Araiza Garaygordobil, MD, MSc

  Instituto Nacional de Cardiología Ignacio Chávez

  PRINCIPAL INVESTIGATOR

• Alexandra Arias Mendoza, MD

  Instituto Nacional de Cardiología Ignacio Chávez

  STUDY DIRECTOR

Central Study Contacts

Diego Araiza Garaygordobil, MD, MSc

CONTACT

55 5573 2911; dargaray@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 10, 2022
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2024
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

ME (2)