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Paradigm Shift in the Treatment of Patients With ACS

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ClinicalTrials.gov Identifier: NCT02041650
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Yu Bo, Harbin Medical University

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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome
Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arm Intervention/treatment
Patients with ACS treated medically Drug: Ticagrelor



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041650


Locations
China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
Sponsors and Collaborators
Yu Bo
Massachusetts General Hospital
Investigators
Principal Investigator: Bo Yu, MD, PhD The Second Affiliated Hospital of Harbin Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yu Bo, Director of Cardiology of The 2nd Affiliated Hospital of Harbin Medical University, Harbin Medical University
ClinicalTrials.gov Identifier: NCT02041650     History of Changes
Other Study ID Numbers: ISSBRIL0186
ISSBRIL0186 ( Other Identifier: HarbinMU )
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs