Paradigm Shift in the Treatment of Patients With ACS

NCT02041650 | Completed Phase 4 DMC

• 1 other identifier: ISSBRIL0186
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cardiovascular adverse events

  30 days and 12 months

Study Arms (1)

Patients with ACS treated medically

OTHER

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Patients with ACS treated medically

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yu Bo: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Related Publications (5)

• Seegers LM, Yeh DD, Wood MJ, Yonetsu T, Minami Y, Araki M, Nakajima A, Yuki H, Ako J, Soeda T, Kurihara O, Higuma T, Kimura S, Adriaenssens T, Nef HM, Lee H, McNulty I, Sugiyama T, Kakuta T, Jang IK. Cardiovascular Risk Factors and Culprit Plaque Characteristics in Women With Acute Coronary Syndromes. Am J Cardiol. 2023 Nov 15;207:13-20. doi: 10.1016/j.amjcard.2023.08.152. Epub 2023 Sep 16.

  PMID: 37722196 DERIVED

• Zeng M, Zhao C, Bao X, Liu M, He L, Xu Y, Meng W, Qin Y, Weng Z, Yi B, Zhang D, Wang S, Luo X, Lv Y, Chen X, Sun Q, Feng X, Gao Z, Sun Y, Demuyakor A, Li J, Hu S, Guagliumi G, Mintz GS, Jia H, Yu B. Clinical Characteristics and Prognosis of MINOCA Caused by Atherosclerotic and Nonatherosclerotic Mechanisms Assessed by OCT. JACC Cardiovasc Imaging. 2023 Apr;16(4):521-532. doi: 10.1016/j.jcmg.2022.10.023. Epub 2022 Dec 14.

  PMID: 36648054 DERIVED

• 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.

  PMID: 35306029 DERIVED

• 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.

  PMID: 34569250 DERIVED

• 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.

  PMID: 29246916 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Bo Yu, MD, PhD

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Cardiology of The 2nd Affiliated Hospital of Harbin Medical University

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 22, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

CN (1)