Status:
UNKNOWN
Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Conditions:
High Bleeding Risk
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous ...
Eligibility Criteria
Inclusion
- Patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or coronary bypass graft suitable for percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by DES, and has at least 1 major or 2 minor Academic Research Consortium High Bleeding Risk criteria:
- Major criteria:
- 1\. Anticipated use of long-term oral anticoagulation
- 2\. Severe or end-stage Chronic Kidney Disease (CKD) (eGFR \<30 mL/min)
- 3\. Hemoglobin \< 11 g/dL
- 4\. Spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent.
- 5\. Moderate or severe baseline thrombocytopenia (\<100,000/uL)
- 6\. Chronic bleeding diathesis
- 7\. Liver cirrhosis with portal hypertension
- 8\. Active malignancy (excluding nonmelanoma skin cancer) within the past 12 months
- 9\. Previous spontaneous intracranial hemorrhage
- 10\. Previous traumatic intracranial hemorrhage within the past 12 months
- 11\. Presence of Brain Arteriovenous malformation (AVM)
- 12\. Moderate or severe ischemic stroke (NIHSS score equal or more than 5) within the past 6 months
- 13\. Non-deferrable major surgery on DAPT
- 14\. Recent major surgery or major trauma within 30 days before PCI
- Minor Criteria:
- 1\. Age 75 years old and older
- 2\. Moderate CKD (eGFR 30-59 mL/min)
- 3\. Hemoglobin 11 - 12.9 g/dL in men and 11 - 11.9 g/dL in women
- 4\. Spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion
- 5\. Long term use of NSAIDs or steroids
- 6\. Any ischemic stroke at any time not meeting major criterion
Exclusion
- STEMI undergoing primary PCI
- Cardiogenic shock or resuscitation with uncertain neurological status at arrival to PCI
- Unprotected left main lesion
- Reference diameter larger or shorter than available stents
- Life expectancy \< 12 months
- In-stent restenosis o thrombosis of previous stent
- Inability to give written consent
Key Trial Info
Start Date :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05240781
Start Date
September 29 2021
End Date
February 28 2025
Last Update
March 4 2022
Active Locations (1)
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1
Instituto Nacional de Cardiología "Ignacio Chávez"
Mexico City, Mexico, 14080