Paradigm Shift in the Treatment of Patients With ACS

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor

• Registration Number: NCT02041650
• Lead Sponsor: Yu Bo

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Study Start: 2014-08
• Primary Completion: 2016-04
• Study Completion: 2017-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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%.

• Life expectancy < 1 year.
• Contraindication to the contrast media.
• Creatinine level > 2.0 mg/dL or end-stage kidney disease.
• Serious liver dysfunction.
• Patients with hemodynamic or electrical instability (including shock).
• Any contraindication against the use of ticagrelor.
• Investigator considers the patient is not suitable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with ACS treated medically	Ticagrelor	-

Primary Outcome Measures

Name	Time	Method
Reduction of thrombus burden by OCT	30 days	The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular adverse events	30 days and 12 months	In patients treated conservatively, the safety objectives are to evaluate the occurrence of any adverse events during1 month follow up (re-infarction, re-hospitalization, revascularization by PCI or CABG, cardiac death, stoke, and major bleeding).

Trial Locations

Locations (1)

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China