Comparing two types of stents for diabetic patients with coronary artery disease
Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus
This study is testing which of two types of heart stents works better for people with diabetes who are having heart procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 860 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cardiologia Ignacio Chavez Academic / other |
| Locations | 1 site (Mexico City, Tlalpan) |
| Trial ID | NCT04660240 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, controlled, and blind study designed to compare the effectiveness of two sirolimus-eluting stents, the Abluminus and the Orsiro, in patients with diabetes mellitus undergoing percutaneous coronary intervention. The primary focus is to assess target lesion failure (TLF) rates at 12 months post-procedure. Given the higher cardiovascular risks associated with diabetes, this study aims to determine which stent provides better long-term outcomes for these patients. The trial is conducted at a single center in Mexico, where diabetes prevalence is notably high.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women over 18 years old with a diagnosis of diabetes mellitus and coronary artery disease requiring stenting.
Not a fit: Patients with cardiogenic shock or severe allergies to the study medications or contrast medium may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stent options for diabetic patients, potentially reducing cardiovascular events and enhancing long-term outcomes.
How similar studies have performed: Previous studies have shown promising results with sirolimus-eluting stents in diabetic patients, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women over 18 years of age. * Provide informed consent and agree to follow up as stipulated in the protocol. * Diabetes mellitus. Whether it is DM 1 or 2 previously diagnosed or newly diagnosed by: * Fasting glucose\> 126 mg / dl (for study terms, fasting will be defined as the absence of caloric intake for\> 8 hours) * Tolerance curve to glucose (75 grams of glucose orally) with a glycemia at 2 hours\> 200 mg / dl or, * HbA1C\> 6.5%. * Coronary artery disease including chronic coronary syndrome, silent ischemia, or non-ST-segment elevation acute coronary ischemic syndrome. * Presence of 1 or more de novo coronary lesions in native coronary arteries with a site of maximum stenosis\> 50% that may be amenable to stenting; without limitation in the number of lesions or vessels affected. Exclusion Criteria: * Cardiogenic shock. * Allergy to acetylsalicylic acid, clopidogrel, ticagrelor, prasugrel, heparin, sirolimus or contrast medium, which cannot be adequately premedicated. * Acute ST-segment elevation myocardial infarction candidate for primary or urgent coronary angioplasty. * Left main coronary artery disease. * In-stent restenosis. * Lesions in venous or arterial grafts. * Surgery (cardiac or non-cardiac) planned within 6 months of PCI, unless dual antiplatelet therapy can be continued in the periprocedural period. * Inability to provide informed consent. * Life expectancy \<1 year
Where this trial is running
Mexico City, Tlalpan
- Instituto Nacional de Cardiología Ignacio Chávez — Mexico City, Tlalpan, Mexico (Recruiting)
Study contacts
- Principal investigator: Julio I Farjat Pasos, MD MSc — Instituto Nacional de Cardiología Ignacio Chávez
- Study coordinator: Alejandra D Portillo Romero, MD
- Email: aleportilloromero@gmail.com
- Phone: +52 55 5573 2911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.