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Coronary Artery EctasiaPhase 4OVER-TIME IINCT07511257

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

A Phase 4 study testing Aspirin 100 mg, Clopidogrel 75 mg and Rivaroxaban 15 mg in people with Coronary Artery Ectasia and Acute Coronary Syndromes (ACS), run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Aspirin 100 mg, Clopidogrel 75 mg and Rivaroxaban 15 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
326 participants
Where
1 siteMexico
Study dates
11 Feb 2026to Jun 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Direccion de Investigación Instituto Nacional de Cardiología contact

+52 5555732911

comite.investigacion@cardiologia.org.mx

Mexico1 site, 1 recruiting

  • Instituto Nacional de Cardiologia "Ignacio Chávez"

    Mexico City, Tlalpan, 14080

    Comite de Investigación, +52 5555732911, comite.investigacion@cardiologia.org.mx

    Diego Araiza Garaygordobil, MD MSc PhD

    Recruiting

Other trials in Mexico

About this study

Official title: Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy Plus Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: A Multicenter Randomized Clinical Trial

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.

Read the detailed description

Coronary artery ectasia (CAE) is defined as an abnormal dilatation of a coronary artery segment measuring at least 50% greater than the diameter of the adjacent normal segment. Although relatively uncommon, CAE represents a clinically relevant phenotype of coronary artery disease. Its reported prevalence ranges from 0.3% to 4.9% worldwide; however, higher frequencies have been described in certain populations. At the National Institute of Cardiology "Ignacio Chávez" (INCICh) in Mexico, a prevalence of approximately 10.3% has been documented among patients presenting with ST-segment elevation myocardial infarction (STEMI), highlighting the importance of studying this condition in the Mexican population.

The pathophysiology of CAE involves abnormal coronary blood flow dynamics, including turbulent flow and blood stasis within dilated segments. These changes may promote thrombus formation through multiple mechanisms, including platelet activation, local inflammatory processes, endothelial dysfunction, and potential prothrombotic states. Genetic susceptibility and molecular pathways related to vascular remodeling may also contribute to the development and progression of the disease. Clinically, patients with CAE have been associated with a higher risk of angina, myocardial infarction, distal embolization, and complications during percutaneous coronary intervention.

Despite its clinical significance, the optimal antithrombotic strategy in patients with acute coronary syndrome (ACS) and CAE remains uncertain. Dual antiplatelet therapy (DAPT), typically consisting of aspirin and a P2Y12 inhibitor, is the most commonly used treatment. However, given the propensity for thrombus formation related to abnormal flow conditions in ectatic coronary segments, anticoagulation has been proposed as a potentially beneficial therapeutic strategy.

The exploratory OVERTIME trial conducted at INCICh compared an antithrombotic regimen consisting of antiplatelet monotherapy plus a direct oral anticoagulant (clopidogrel 75 mg plus rivaroxaban 15 mg daily) with standard dual antiplatelet therapy (aspirin 100 mg plus clopidogrel 75 mg daily) in patients with ACS and CAE. Although limited by sample size, the study demonstrated a numerical reduction in major adverse cardiovascular events and a shorter endogenous fibrinolysis time among patients receiving the combination of antiplatelet therapy and anticoagulation, without a significant increase in bleeding events.

These findings support the hypothesis that anticoagulation combined with antiplatelet therapy may improve clinical outcomes in this high-risk population. However, larger randomized studies are needed to confirm these results and provide definitive evidence to guide clinical management.

The OVER-TIME II trial is a multicenter, randomized clinical trial designed to compare two antithrombotic strategies in patients with ACS and angiographically confirmed CAE: (1) standard dual antiplatelet therapy and (2) antiplatelet monotherapy combined with oral anticoagulation. The primary objective is to evaluate whether the addition of anticoagulation reduces major cardiovascular events without significantly increasing bleeding risk.

In addition to the clinical trial component, the study will incorporate a translational research arm. Peripheral blood samples will be collected to investigate genetic variants and DNA and RNA expression profiles that may be associated with susceptibility to CAE, disease progression, and differential response to antithrombotic therapy. These analyses aim to improve the understanding of the biological mechanisms underlying CAE and to identify potential biomarkers that could inform future personalized treatment strategies.

Being tested
Aspirin 100 mg, Clopidogrel 75 mg, Rivaroxaban 15 mg
Keywords
Coronary Artery Ectasia, Acute Coronary Syndrome, Anticoagulation, Dual Antiplatelet Therapy
Medical subject headings
Coronary Aneurysm, Acute Coronary Syndrome, ST Elevation Myocardial Infarction

What participants receive

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

  • Aspirin 100 mgDrug

    Participants receive aspirin 100 mg once daily

  • Clopidogrel 75 mgDrug

    Participants receive clopidogrel 75 mg once daily

  • Rivaroxaban 15 mgDrug

    Participants receive oral anticoagulation using rivaroxaban 15 mg once daily

Study groups in NCT07511257
Study groupRoleWhat they receive
Dual Antiplatelet TherapyActive comparatorParticipants receive standard dual antiplatelet therapy consisting of aspirin 100 mg once daily plus clopidogrel 75 mg once daily
Receives: Drug: Aspirin 100 mg; Drug: Clopidogrel 75 mg
Antiplatelet Monotherapy Plus Oral AnticoagulationExperimentalParticipants receive antiplatelet monotherapy with clopidogrel 75 mg once daily plus oral anticoagulation using rivaroxaban 15 mg once daily
Receives: Drug: Clopidogrel 75 mg; Drug: Rivaroxaban 15 mg

What is being measured

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

  1. 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).

    Measured: 12 months

  2. 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).

    Measured: 12 months

Secondary outcomes (2)

  1. Individual Components of the Major Adverse Cardiovascular Event Composite

    Incidence of each individual component of the primary efficacy composite endpoint (cardiovascular death, non-fatal myocardial infarction, and repeat coronary revascularization) in patients with coronary artery ectasia following acute coronary syndrome, according to the assigned antithrombotic treatment strategy.

    Measured: 12 months

  2. Individual Bleeding Events According to the BARC Classification

    Incidence of individual bleeding events 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.

    Measured: 12 months

Timeline

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

  1. First posted6 Apr 2026
  2. Study start11 Feb 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
326 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07511257
Sponsor's protocol ID
26-1556
Acronym
OVER-TIME II
Status last verified
Apr 2026
First submitted
30 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Some information might be available upon reasonable request.

Publications

  • Solis-Jimenez F, Esparza XL, Guzman-Solorzano HP, Villalobos-Pedroza M, Morales-Villamil LA, Diaz-Herrera BA, Hernandez-Pastrana S, Gopar-Nieto R, Arias-Sanchez EA, Marroquin-Donday LA, Jimenez-Rodriguez GM, Sierra-Lara D, Araiza-Garaygordobil D, Arias-Mendoza A. Anticoagulant versus Antiplatelet Therapy After Acute Coronary Syndromes in Patients with Coronary Artery Ectasia: A Retrospective Cohort Study. Cardiovasc Drugs Ther. 2026 Jun;40(3):1021-1033. doi: 10.1007/s10557-025-07784-0. Epub 2025 Sep 24.

    PubMed 40991139

  • 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.

    PubMed 39615618

  • 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.

    PubMed 29051141

  • 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.

    PubMed 36982889

  • Lu TP, Chuang NC, Cheng CY, Hsu CA, Wang YC, Lin YH, Lee JK, Wu CK, Hwang JJ, Lin LY, Yeh SS, Chien KL, Juang JJ. Genome-wide methylation profiles in coronary artery ectasia. Clin Sci (Lond). 2017 Apr 1;131(7):583-594. doi: 10.1042/CS20160821. Epub 2017 Jan 31.

    PubMed 28143891

  • Dogan A, Tunc B, Ergene O, Ozaydin M, Nazli C, Altinbas A, Gedikli O. Evaluation of overall fibrinolytic activity in patients with coronary artery ectasia: global fibrinolytic capacity. Int J Cardiovasc Imaging. 2003 Dec;19(6):465-71. doi: 10.1023/b:caim.0000004339.30038.8d.

    PubMed 14690185

  • Nunez-Gil IJ, Cerrato E, Bollati M, Nombela-Franco L, Terol B, Alfonso-Rodriguez E, Camacho Freire SJ, Villablanca PA, Amat Santos IJ, de la Torre Hernandez JM, Pascual I, Liebetrau C, Camacho B, Pavani M, Albistur J, Latini RA, Varbella F, Jimenez-Diaz VA, Piraino D, Mancone M, Alfonso F, Linares JA, Rodriguez-Olivares R, Jimenez Mazuecos JM, Palazuelos Molinero J, Sanchez-Grande Flecha A, Gomez-Hospital JA, Ielasi A, Lozano I, Omede P, Bagur R, Ugo F, Medda M, Louka BF, Kala P, Escaned J, Bautista D, Feltes G, Salinas P, Alkhouli M, Macaya C, Fernandez-Ortiz A; CAAR investigators. Coronary artery aneurysms, insights from the international coronary artery aneurysm registry (CAAR). Int J Cardiol. 2020 Jan 15;299:49-55. doi: 10.1016/j.ijcard.2019.05.067. Epub 2019 Jul 19.

    PubMed 31378382

  • Gunasekaran P, Stanojevic D, Drees T, Fritzlen J, Haghnegahdar M, McCullough M, Barua R, Mehta A, Hockstad E, Wiley M, Earnest M, Tadros P, Genton R, Gupta K. Prognostic significance, angiographic characteristics and impact of antithrombotic and anticoagulant therapy on outcomes in high versus low grade coronary artery ectasia: A long-term follow-up study. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1219-1227. doi: 10.1002/ccd.27929. Epub 2018 Nov 4.

    PubMed 30393992

  • Bogana Shanmugam V, Psaltis PJ, T L Wong D, T Meredith I, Malaiapan Y, Ahmar W. Outcomes After Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Caused by Ectatic Infarct Related Arteries. Heart Lung Circ. 2017 Oct;26(10):1059-1068. doi: 10.1016/j.hlc.2016.12.006. Epub 2017 Feb 7.

    PubMed 28216061

  • Yip HK, Chen MC, Wu CJ, Hang CL, Hsieh KY, Fang CY, Yeh KH, Fu M. Clinical features and outcome of coronary artery aneurysm in patients with acute myocardial infarction undergoing a primary percutaneous coronary intervention. Cardiology. 2002;98(3):132-40. doi: 10.1159/000066322.

    PubMed 12417812

  • Hartnell GG, Parnell BM, Pridie RB. Coronary artery ectasia. Its prevalence and clinical significance in 4993 patients. Br Heart J. 1985 Oct;54(4):392-5. doi: 10.1136/hrt.54.4.392.

    PubMed 4052280

  • Markis JE, Joffe CD, Cohn PF, Feen DJ, Herman MV, Gorlin R. Clinical significance of coronary arterial ectasia. Am J Cardiol. 1976 Feb;37(2):217-22. doi: 10.1016/0002-9149(76)90315-5.

    PubMed 1108631

  • Swaye PS, Fisher LD, Litwin P, Vignola PA, Judkins MP, Kemp HG, Mudd JG, Gosselin AJ. Aneurysmal coronary artery disease. Circulation. 1983 Jan;67(1):134-8. doi: 10.1161/01.cir.67.1.134.

    PubMed 6847792

  • Adame-Aviles E, Araiza-Garaygordobil D, Garcia-Mena L, Alcocer-Gamba M, Maldonado-May AC, Alvarez-Santana R, Nieto-Saucedo JR, Rojas-Arriaga AI, Gopar-Nieto R, Sierra-Lara Martinez JD, Marroquin-Donday LA, Diaz-Marin J, Jacobo-Albavera L, Arias-Mendoza MA, Mullasari AS. OVER-TIME II trial: design and rationale of a multicentre randomized study evaluating antithrombotic strategies in patients with acute coronary syndrome and coronary artery ectasia. Eur Heart J Open. 2026 Sep 30;6(6):oeag161. doi: 10.1093/ehjopen/oeag161. eCollection 2026 Nov.

    PubMed 42979093

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin 100 mg, Clopidogrel 75 mg and Rivaroxaban 15 mg in people with Coronary Artery Ectasia and Acute Coronary Syndromes (ACS), run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.

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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Direccion de Investigación Instituto Nacional de Cardiología (+52 5555732911, comite.investigacion@cardiologia.org.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Major Adverse Cardiovascular Event (MACE) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT07511257, which also lists 14 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 9 Apr 2026.

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