Paradigm Shift in the Treatment of Patients With ACS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with ACS treated medically

Group Type OTHER

Ticagrelor

Intervention Type DRUG

Interventions

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Ticagrelor

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No