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Paradigm Shift in the Treatment of Patients With ACS

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ticagrelor

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The 2nd Affiliated Hospital of Harbin Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with ACS treated medically

Arm Description

Outcomes

Primary Outcome Measures

Reduction of thrombus burden by OCT

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

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02041650

First Posted

January 17, 2014

Last Updated

July 9, 2018

Sponsor

Yu Bo

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02041650

Brief Title

Paradigm Shift in the Treatment of Patients With ACS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yu Bo

Collaborators

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with ACS treated medically

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Ticagrelor

Primary Outcome Measure Information:

Title

Reduction of thrombus burden by OCT

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Cardiovascular adverse events

Description

Time Frame

30 days and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Yu, MD, PhD

Organizational Affiliation

The Second Affiliated Hospital of Harbin Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The 2nd Affiliated Hospital of Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150086

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35306029

Citation

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.

Results Reference

derived

PubMed Identifier

34569250

Citation

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.

Results Reference

derived

PubMed Identifier

29246916

Citation

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.

Results Reference

derived

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Paradigm Shift in the Treatment of Patients With ACS

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