Skip to main content
OpenTrials
Completed

NCT Number: NCT02041650

Paradigm Shift in the Treatment of Patients With ACS

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor

Drug

Primary outcomes

  1. Reduction of thrombus burden by OCT

    Time frame: 30 days

    The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.

Secondary outcomes

  1. Cardiovascular adverse events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yu Bo

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 22, 2014
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.