EndoTic - Endothelium and Ticagrelor

Sponsor

Fundación Investigación Sanitaria en León (Other)

Overall Status

Completed

CT.gov ID

NCT02244710

Collaborator

AstraZeneca (Industry)

109

Enrollment

Locations

Arms

18.1

Duration (Months)

36.3

Patients Per Site

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome (ACS)	Drug: Ticagrelor vs Clopidogrel	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor 180mg initial dose next day 90mg BID	Drug: Ticagrelor vs Clopidogrel
Active Comparator: Clopidogrel 600mg po initial dose and 75mg qd starting next day	Drug: Ticagrelor vs Clopidogrel

Arm

Intervention/Treatment

Experimental: Ticagrelor

180mg initial dose next day 90mg BID

Drug: Ticagrelor vs Clopidogrel

Active Comparator: Clopidogrel

600mg po initial dose and 75mg qd starting next day

Drug: Ticagrelor vs Clopidogrel

Outcome Measures

Primary Outcome Measures

Number of cells [Baseline]
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells [48 hours after last chest pain episode]
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)
Number of cells [1 month visit]
EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)

Secondary Outcome Measures

Platelet reactivity [At the time of coronary angiography]
As determined by P2Y12 kits, VerifyNow®
Platelet reactivity [1 month visit]
As determined by P2Y12 kits, VerifyNow®

Other Outcome Measures

Safety: Bleeding and ischemic adverse events [18 months (Study duration)]
Adverse Events collection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Santiago	Santiago de Compostela	La Coruña	Spain
2	Hospital de Leon	Leon		Spain	24008
3	Hospital Universitario de Salamanca	Salamanca		Spain

Sponsors and Collaborators

Fundación Investigación Sanitaria en León
AstraZeneca

Investigators

Principal Investigator: Armando Pérez de Prado, MD, PhD, Fundación Investigación Sanitaria en León
Study Director: M. Belen Vidriales Acosta, MD, PhD, University of Salamanca