EndoTic - Endothelium and Ticagrelor

Acute Coronary Syndrome (ACS) Clinical Trial

Official title:

EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244710
• Other study ID #: ISSBRIL0205
• Secondary ID: 2013-005042-11
• Status: Completed
• Phase: N/A
• First received: September 11, 2014
• Last updated: November 22, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Fundación Investigación Sanitaria en León
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)

Intervention

Drug:
• Ticagrelor vs Clopidogrel

Locations

Country	Name	City	State
Spain	Hospital de Leon	Leon
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Santiago	Santiago de Compostela	La Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Investigación Sanitaria en León	AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: Bleeding and ischemic adverse events	Adverse Events collection	18 months (Study duration)	Yes
Primary	Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	Baseline	No
Primary	Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	48 hours after last chest pain episode	No
Primary	Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	1 month visit	No
Secondary	Platelet reactivity	As determined by P2Y12 kits, VerifyNow®	At the time of coronary angiography	No
Secondary	Platelet reactivity	As determined by P2Y12 kits, VerifyNow®	1 month visit	No