Back to resultsEndoTic - Endothelium and Ticagrelor
Primary Purpose
Acute Coronary Syndrome (ACS)
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ticagrelor vs Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring Circulating Endothelial Cells, Endothelial Progenitor Cells, Acute coronary syndrome (ACS), Ticagrelor
Eligibility Criteria
Inclusion Criteria:
- Willing to sign Informed Consent Form
- 18 yr or older
- Male and female (post menopause or contraception treatment)
- ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
- Planned invasive strategy (coronariography performed within 72hrs after admission)
Exclusion Criteria:
- Aspirin, clopidogrel or ticagrelor allergy.
- Hemorrhagic diathesis or very high risk of bleeding.
- Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
- Limited life expectancy.
- Elective surgery planned.
- High chance of not being able to complete the follow-up period.
Sites / Locations
- Hospital Universitario de Santiago
- Hospital de Leon
- Hospital Universitario de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
Clopidogrel
Arm Description
180mg initial dose next day 90mg BID
600mg po initial dose and 75mg qd starting next day
Outcomes
Primary Outcome Measures
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Secondary Outcome Measures
Platelet reactivity
As determined by P2Y12 kits, VerifyNow®
Platelet reactivity
As determined by P2Y12 kits, VerifyNow®
Full Information
NCT ID
NCT02244710
First Posted
September 11, 2014
Last Updated
November 22, 2016
Sponsor
Fundación Investigación Sanitaria en León
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT02244710
Brief Title
EndoTic - Endothelium and Ticagrelor
Official Title
EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Investigación Sanitaria en León
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).
Detailed Description
ACS Patients in both treatment groups will be assessed:
Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)
Keywords
Circulating Endothelial Cells, Endothelial Progenitor Cells, Acute coronary syndrome (ACS), Ticagrelor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
180mg initial dose next day 90mg BID
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
600mg po initial dose and 75mg qd starting next day
Intervention Type
Drug
Intervention Name(s)
Ticagrelor vs Clopidogrel
Primary Outcome Measure Information:
Title
Number of cells
Description
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Time Frame
Baseline
Title
Number of cells
Description
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Time Frame
48 hours after last chest pain episode
Title
Number of cells
Description
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Time Frame
1 month visit
Secondary Outcome Measure Information:
Title
Platelet reactivity
Description
As determined by P2Y12 kits, VerifyNow®
Time Frame
At the time of coronary angiography
Title
Platelet reactivity
Description
As determined by P2Y12 kits, VerifyNow®
Time Frame
1 month visit
Other Pre-specified Outcome Measures:
Title
Safety: Bleeding and ischemic adverse events
Description
Adverse Events collection
Time Frame
18 months (Study duration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing to sign Informed Consent Form
18 yr or older
Male and female (post menopause or contraception treatment)
ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
Planned invasive strategy (coronariography performed within 72hrs after admission)
Exclusion Criteria:
Aspirin, clopidogrel or ticagrelor allergy.
Hemorrhagic diathesis or very high risk of bleeding.
Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
Limited life expectancy.
Elective surgery planned.
High chance of not being able to complete the follow-up period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando Pérez de Prado, MD, PhD
Organizational Affiliation
Fundación Investigación Sanitaria en León
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Belen Vidriales Acosta, MD, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Santiago
City
Santiago de Compostela
State/Province
La Coruña
Country
Spain
Facility Name
Hospital de Leon
City
Leon
ZIP/Postal Code
24008
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
12. IPD Sharing Statement
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EndoTic - Endothelium and Ticagrelor
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