Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study

NCT01826175 | Withdrawn Phase 4

• 1 other identifier: 2013P000225
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Keywords

Optical Coherence Tomography; ticagrelor; clopidogrel

Outcome Measures

Primary Outcomes (1)

• Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.

  The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.

  Thrombus burden will be measured at the end of the coronary artery stenting procedure.

Secondary Outcomes (2)

• PRI (platelet reactivity index) as measured by the PLT-VASP assay.

  PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).

• P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.

  P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).

Other Outcomes (1)

• PCI- related myocardial infarction (MI)

  PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.

Drug: Ticagrelor; Device: Optical Coherence Tomography

Clopidogrel

ACTIVE COMPARATOR

Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.

Drug: Clopidogrel; Device: Optical Coherence Tomography

Interventions

Ticagrelor DRUG

Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.

Also known as: Brilinta, Brilique, Possia

Ticagrelor

Clopidogrel DRUG

Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.

Also known as: Plavix

Clopidogrel

Optical Coherence Tomography DEVICE

Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.

Also known as: OCT

Clopidogrel; Ticagrelor

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Characteristics:
• Males and non-pregnant females \> 18 and \< 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
• Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion
• ECG changes indicative of new ischemia
• Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.
• Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)
• Lesion Characteristics on Diagnostic Coronary Angiography
• De novo lesions in native coronary arteries found by diagnostic coronary angiography
• Angiographic stenosis \<100%
• Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

You may not qualify if:

• Subjects who are unable or unwilling to sign the informed consent form
• Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
• Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction \< 30%
• Subjects with an ST elevation myocardial infarction
• Subjects with hemodynamic or electrical instability (including shock)
• Subjects diagnosed with severe, non-catheter-related coronary artery spasm
• Subjects who are or may be pregnant
• Subjects with known allergies to contrast media
• Subjects with renal failure as defined by eGFR \< 60.
• History of TIA or stroke \< 6 months
• History of hemorrhagic stroke
• Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
• Lesion located in the left main coronary artery
• Lesions that are heavily calcified
• Lesions where OCT cannot be performed due to technical difficulties

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive 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; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Ik-Kyung Jang, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)