Acute Coronary Syndrome (ACS) Clinical Trial
Official title:
EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy
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 |
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).
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Fundación Investigación Sanitaria en León | AstraZeneca |
Spain,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00385138 -
Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.
|
Phase 3 | |
Completed |
NCT01944800 -
Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome
|
Phase 4 | |
Completed |
NCT02290080 -
Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction by Biomarkers
|
Phase 3 | |
Completed |
NCT02286544 -
Effects of Oxygen Treatment on Mechanisms Involved in Ischemia-reperfusion Injury: A Pilot Study in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01405287 -
Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT
|
Phase 2 | |
Completed |
NCT00767507 -
Maintenance of Platelet Inhibition With Cangrelor
|
Phase 2 | |
Completed |
NCT03672097 -
Prasugrel Switching Study in Patients With Acute Coronary Syndrome (ACS) Who Underwent Percutaneous Coronary Intervention (PCI)
|
Phase 4 | |
Completed |
NCT00399880 -
Improving Medication Adherence Through Graphically Enhanced Interventions in Acute Coronary Syndromes
|
N/A | |
Completed |
NCT02430493 -
Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients
|
N/A | |
Completed |
NCT01994577 -
Optimum Troponin Cutoffs for ACS in the ED
|
||
Completed |
NCT00313300 -
Safety Study of Apixaban in Recent Acute Coronary Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT04090281 -
Implementing Precision Medicine Approaches to Guide Anti-platelet Selection
|
Phase 4 | |
Active, not recruiting |
NCT03581578 -
VITROS Immunodiagnostic Products hs Troponin I
|
||
Recruiting |
NCT04116931 -
OPTImal Management of Antithrombotic Agents: OPTIMA-5
|
Phase 4 | |
Not yet recruiting |
NCT06449274 -
RESTORE Imaging: an OCT-IVUS Imaging Substudy of RESTORE Trial
|
N/A | |
Completed |
NCT02171065 -
PROSPECT II & PROSPECT ABSORB - an Integrated Natural History Study and Randomized Trial.
|
N/A | |
Completed |
NCT00855257 -
Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Acute Coronary Syndrome
|
Phase 3 | |
Completed |
NCT02733341 -
The Effect of IV Cangrelor and Oral Ticagrelor Study
|
Phase 4 | |
Completed |
NCT02184884 -
Effect of Perioperative Clopidogrel Responsiveness on Ischemic Outcome in Patients With Acute Coronary Syndrome Undergoing Off-pump Coronary Artery Bypass Surgery
|
||
Completed |
NCT00932100 -
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
|
Phase 2 |