Paradigm Shift in the Treatment of Patients With ACS

Yu Bo

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Ticagrelor

Study type

Interventional

Funder types

Other

Identifiers

NCT02041650

ISSBRIL0186 (Other Identifier)

Details and patient eligibility

About

This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men or non-pregnant women >18 years of age and < 75 years of age
Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 12 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest.
Culprit lesion located in a native coronary artery
TIMI flow grade 3 and diameter stenosis < 70% on angiogram
Definite erosion defined by OCT
Patients able to provide written informed consent

Exclusion criteria

Left ventricular ejection fraction < 30%.