Paradigm Shift in the Treatment of Patients With ACS

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • The 2nd Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with ACS treated medically	Drug: Ticagrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yu Bo
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Bo Yu, MD, PhD, The Second Affiliated Hospital of Harbin Medical University

Publications and helpful links

General Publications

• Araki M, Yonetsu T, Kurihara O, Nakajima A, Lee H, Soeda T, Minami Y, Higuma T, Kimura S, Takano M, Yan BP, Adriaenssens T, Boeder NF, Nef HM, Kim CJ, McNulty I, Crea F, Kakuta T, Jang IK. Age and Phenotype of Patients With Plaque Erosion. J Am Heart Assoc. 2021 Oct 5;10(19):e020691. doi: 10.1161/JAHA.120.020691. Epub 2021 Sep 25.
• Kim HO, Jiang B, Poon EKW, Thondapu V, Kim CJ, Kurihara O, Araki M, Nakajima A, Mamon C, Dijkstra J, Lee H, Ooi A, Barlis P, Jang IK. High endothelial shear stress and stress gradient at plaque erosion persist up to 12 months. Int J Cardiol. 2022 Jun 15;357:1-7. doi: 10.1016/j.ijcard.2022.03.035. Epub 2022 Mar 16.
• Xing L, Yamamoto E, Sugiyama T, Jia H, Ma L, Hu S, Wang C, Zhu Y, Li L, Xu M, Liu H, Bryniarski K, Hou J, Zhang S, Lee H, Yu B, Jang IK. EROSION Study (Effective Anti-Thrombotic Therapy Without Stenting: Intravascular Optical Coherence Tomography-Based Management in Plaque Erosion): A 1-Year Follow-Up Report. Circ Cardiovasc Interv. 2017 Dec;10(12):e005860. doi: 10.1161/CIRCINTERVENTIONS.117.005860.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: ISSBRIL0186 (Other Identifier: HarbinMU)