Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study

This study has been withdrawn prior to enrollment.
(Despite a large number of patients screened, very few met eligibility guidelines.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01916902
First received: August 2, 2013
Last updated: May 23, 2014
Last verified: May 2014

August 2, 2013
May 23, 2014
February 2014
February 2015   (final data collection date for primary outcome measure)
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry. [ Time Frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure. ] [ Designated as safety issue: No ]
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
Same as current
Complete list of historical versions of study NCT01916902 on ClinicalTrials.gov Archive Site
  • PRI (platelet reactivity index) as measured bu the PLT-VASP assay. [ Time Frame: PRI iwill be measured at the time of OCT image acquisition. ] [ Designated as safety issue: No ]
    The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
  • P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay. [ Time Frame: P2Y12 will be measured at the time of OCT image acquisition. ] [ Designated as safety issue: No ]
    The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
Same as current
PCI-related myocardial infarction (MI) [ Time Frame: PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure. ] [ Designated as safety issue: No ]
PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction.
Same as current
 
Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study
Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: an Optical Coherence Tomography Study

Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Acute Coronary Syndrome
  • Coronary Artery Disease
  • Drug: Ticagrelor- Delayed Administration
    Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
  • Drug: Ticagrelor- Immediate Administration
    Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
  • Procedure: Optical Coherence Tomography
  • Active Comparator: Ticagrelor- Delayed Administration
    Subjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting.
    Interventions:
    • Drug: Ticagrelor- Delayed Administration
    • Procedure: Optical Coherence Tomography
  • Active Comparator: Ticagrelor- Immediate Administration
    Subjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting.
    Interventions:
    • Drug: Ticagrelor- Immediate Administration
    • Procedure: Optical Coherence Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patient Characteristics:

  1. Males and non-pregnant females > or equal to 18 and < or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)
  2. Patients likely to be scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)

Lesion Characteristics on Diagnostic Coronary Angiography:

  1. De novo lesions in native coronary arteries found by diagnostic coronary angiography
  2. Angiographic stenosis <100%
  3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

Exclusion Criteria:

Patient Specific Exclusion Criteria:

  1. Subjects who are unable or unwilling to sign the informed consent form.
  2. Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
  3. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
  4. Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
  5. Subjects with an ST elevation myocardial infarction.
  6. Subjects with hemodynamic or electrical instability (including shock).
  7. Subjects diagnosed with severe, non-catheter-related coronary artery spasm.
  8. Subjects who are or may be pregnant.
  9. Subjects with known allergies to contrast media.
  10. Subjects with eGFR < 60 ml/min/1.73m2.
  11. Subjects currently taking oral anticoagulants with an absolute contraindication to discontinuation of anticoagulation.
  12. History of TIA or stroke < 6 months.
  13. History of hemorrhagic stroke.
  14. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
  15. Cardiac catheterization scheduled within 4 hours of randomization or more then 72 hours after randomization.

Lesion Specific Exclusion Criteria. These exclusion criteria apply to the target lesion to be imaged by OCT.

  1. Lesions located in the left main coronary artery
  2. Lesions that are heavily calcified
  3. Lesions where OCT cannot be performed due to technical difficulties
  4. Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
  5. Lesions in saphenous vein grafts or arterial conduits.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01916902
2013P001322
Not Provided
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
AstraZeneca
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
Massachusetts General Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP