EndoTic - Endothelium and Ticagrelor
2 other identifiers
interventional
109
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 23, 2016
November 1, 2016
1.5 years
September 11, 2014
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Baseline
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
48 hours after last chest pain episode
Number of cells
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
1 month visit
Secondary Outcomes (2)
Platelet reactivity
At the time of coronary angiography
Platelet reactivity
1 month visit
Other Outcomes (1)
Safety: Bleeding and ischemic adverse events
18 months (Study duration)
Study Arms (2)
Ticagrelor
EXPERIMENTAL180mg initial dose next day 90mg BID
Clopidogrel
ACTIVE COMPARATOR600mg po initial dose and 75mg qd starting next day
Interventions
Eligibility Criteria
You may qualify if:
- Willing to sign Informed Consent Form
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación Investigación Sanitaria en Leónlead
- AstraZenecacollaborator
Study Sites (3)
Hospital Universitario de Santiago
Santiago de Compostela, La Coruña, Spain
Hospital de Leon
León, Leon, 24008, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armando Pérez de Prado, MD, PhD
Fundación Investigación Sanitaria en León
- STUDY DIRECTOR
M. Belen Vidriales Acosta, MD, PhD
University of Salamanca
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2014
First Posted
September 19, 2014
Study Start
March 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 23, 2016
Record last verified: 2016-11