Multicenter Trial of Antithrombotic Strategies in Acute Coronary Syndrome With Coronary Artery Ectasia

NCT07511257 | Recruiting Phase 4

• 1 other identifier: 26-1556
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery ectasia (CAE) is a condition in which a coronary artery becomes abnormally dilated, measuring at least 50% larger than the adjacent normal segment. Although relatively uncommon, CAE is clinically important because it can lead to abnormal blood flow and increase the risk of blood clot formation. Patients with CAE are at higher risk of angina, myocardial infarction, and complications during coronary interventions. Despite these risks, the optimal antithrombotic treatment for patients with acute coronary syndrome (ACS) and CAE remains uncertain. Dual antiplatelet therapy (aspirin plus clopidogrel) is currently the most commonly used treatment. However, the abnormal blood flow patterns observed in CAE may promote clot formation through mechanisms that could potentially be better addressed with anticoagulant therapy. The OVER-TIME II trial is a multicenter randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and CAE: standard dual antiplatelet therapy versus antiplatelet monotherapy combined with anticoagulation. The study aims to determine whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.

Conditions

Coronary Artery Ectasia; Acute Coronary Syndromes (ACS); STEMI - ST Elevation Myocardial Infarction; NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

Keywords

Coronary Artery Ectasia; Acute Coronary Syndrome; Anticoagulation; Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (2)

• Time to First Major Adverse Cardiovascular Event (MACE)

  Time to first occurrence of the composite of cardiovascular death, non-fatal myocardial infarction, or repeat coronary revascularization in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy (dual antiplatelet therapy versus clopidogrel plus rivaroxaban).

  12 months

• Time to First Bleeding Event According to the BARC Classification

  Time to first occurrence of a composite of major or minor bleeding events defined according to the Bleeding Academic Research Consortium (BARC) classification in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy (dual antiplatelet therapy versus clopidogrel plus rivaroxaban).

  12 months

Secondary Outcomes (2)

• Individual Components of the Major Adverse Cardiovascular Event Composite

  12 months

• Individual Bleeding Events According to the BARC Classification

  12 months

Other Outcomes (1)

• Genetic Variants and Gene Expression Profiles Associated With Coronary Artery Ectasia and Treatment Response

  Baseline and 12 months

Study Arms (2)

Dual Antiplatelet Therapy

ACTIVE COMPARATOR

Participants receive standard dual antiplatelet therapy consisting of aspirin 100 mg once daily plus clopidogrel 75 mg once daily

Drug: Aspirin 100 mg; Drug: Clopidogrel 75 mg

Antiplatelet Monotherapy Plus Oral Anticoagulation

EXPERIMENTAL

Participants receive antiplatelet monotherapy with clopidogrel 75 mg once daily plus oral anticoagulation using rivaroxaban 15 mg once daily

Drug: Clopidogrel 75 mg; Drug: Rivaroxaban 15 mg

Interventions

Aspirin 100 mg DRUG

Participants receive aspirin 100 mg once daily

Dual Antiplatelet Therapy

Clopidogrel 75 mg DRUG

Participants receive clopidogrel 75 mg once daily

Antiplatelet Monotherapy Plus Oral Anticoagulation; Dual Antiplatelet Therapy

Rivaroxaban 15 mg DRUG

Participants receive oral anticoagulation using rivaroxaban 15 mg once daily

Antiplatelet Monotherapy Plus Oral Anticoagulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years, of either sex, hospitalized with acute coronary syndrome (ACS) with or without ST-segment elevation.
• Recent ACS within 7 days prior to enrollment, defined by all of the following:
• Clinical presentation consistent with acute coronary syndrome.
• Elevated high-sensitivity cardiac troponin above the 99th percentile.
• Presence or absence of persistent ST-segment elevation.
• Coronary artery ectasia in the culprit coronary artery, defined by all of the following:
• The presence of ectasia will be determined by agreement of two expert interventional cardiologists, and will be confirmed by quantitative coronary angiography (QCA).
• Identification of a culprit artery consistent with the electrocardiographic territory involved (in cases with ST-segment elevation) or with angiographic features suggestive of an atherothrombotic event, such as the presence of thrombus or reduced coronary flow.
• Hospital admission lasting more than 24 hours.
• Management with either percutaneous coronary intervention or medical therapy, as determined by the treating medical team. Intracoronary interventions such as stent implantation, balloon angioplasty, or thrombus aspiration are permitted.
• Ability and willingness to provide written informed consent and to participate in the study.

You may not qualify if:

• Pregnant women.
• Current indication for temporary or long-term anticoagulation therapy at the time of enrollment.
• Severe chronic kidney disease, defined as KDIGO stage G4 or higher (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²).
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² at hospital discharge.
• History of major bleeding, active bleeding, or high bleeding risk, including but not limited to gastrointestinal bleeding, intracranial hemorrhage, or other conditions considered by the treating physician to confer a high risk of bleeding.
• Advanced heart failure, defined as left ventricular ejection fraction (LVEF) \<30% plus at least one of the following:
• More than two hospitalizations or unplanned emergency department visits for heart failure in the past year, or
• NYHA functional class III or IV symptoms despite optimal medical therapy at enrollment or within the previous 3 months.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia "Ignacio Chávez"

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

Related Publications (13)

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• 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 BACKGROUND

• Doi T, Kataoka Y, Noguchi T, Shibata T, Nakashima T, Kawakami S, Nakao K, Fujino M, Nagai T, Kanaya T, Tahara Y, Asaumi Y, Tsuda E, Nakai M, Nishimura K, Anzai T, Kusano K, Shimokawa H, Goto Y, Yasuda S. Coronary Artery Ectasia Predicts Future Cardiac Events in Patients With Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2017 Dec;37(12):2350-2355. doi: 10.1161/ATVBAHA.117.309683. Epub 2017 Oct 19.

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• Iwanczyk S, Lehmann T, Cieslewicz A, Malesza K, Wozniak P, Hertel A, Krupka G, Jagodzinski PP, Grygier M, Lesiak M, Araszkiewicz A. Circulating miRNA-451a and miRNA-328-3p as Potential Markers of Coronary Artery Aneurysmal Disease. Int J Mol Sci. 2023 Mar 18;24(6):5817. doi: 10.3390/ijms24065817.

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  PMID: 6847792 BACKGROUND

MeSH Terms

Conditions

Coronary Aneurysm; Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Interventions

Aspirin; Clopidogrel; Rivaroxaban

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Direccion de Investigación Instituto Nacional de Cardiología

CONTACT

+52 5555732911; comite.investigacion@cardiologia.org.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Cardiologist in the Coronary Care Unit and Emergency Department

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

ME (1)