Paradigm Shift in the Treatment of Patients With ACS

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041650
• Other study ID #: ISSBRIL0186
• Secondary ID: ISSBRIL0186
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang

Sponsors (2)

Lead Sponsor	Collaborator
Yu Bo	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of thrombus burden by OCT	The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.	30 days
Secondary	Cardiovascular adverse events	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).	30 days and 12 months