Assessment of Coronary Flow Reserve by Doppler Flow Wire in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Differences Between the Loading Dose of Ticagrelor and Clopidogrel
1 other identifier
interventional
88
1 country
1
Brief Summary
The administration of these drugs is realized according to the European Society of Cardiology guidelines. All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an activated clotting time of \>250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel (600 mg) immediately before the revascularization. The list of assignment to ticagrelor or clopidogrel will be generated by a computer according to a 1:1 randomization. Primary Percutaneous Coronary Intervention will be performed according to standard clinical practice using femoral or radial artery Judkins approach via six or seven French heath insertion. After crossing the target occlusive Lesion, coronary stenting will be performed based on standard practice. Patients subsequently will receive heparin for 48 hr, aspirin 100 mg daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12 months. Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to operator discretion. All patients will provide written informed consent before entering the study. Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as standard practice. Then, all the pre-, intra-, and post-procedure data patients will be collected in a database. Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention. Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Clopidogrel (600 mg). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions. Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with Acute Coronary Syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System. Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
1 active site
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
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedJanuary 10, 2014
January 1, 2014
10 months
December 18, 2013
January 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of coronary flow reserve
2 hours after the loading dose of drugs.
Study Arms (2)
ticagrelor
ACTIVE COMPARATORticagrelor: loading dose of 180 mg and maintaining dose of 90 mg twice daily in NSTEMI and STEMI (Class I B) patients;
clopidogrel
ACTIVE COMPARATORclopidogrel: loading dose of 600 mg and maintaining dose of 75 mg daily in NSTEMI (Class I B) and STEMI (Class I C) patients.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with acute coronary syndromes undergoing Percutaneous Coronary Intervention with stent implantation;
- Patients ≥ 18 and ≤ 75 years old.
- Signed informed consent;
You may not qualify if:
- Patients with stable angina;
- prior myocardial infarction;
- prior revascularization (Percutaneous Coronary Intervention or coronary artery bypass grafting);
- Clopidogrel and/or Ticagrelor contraindications (history of intracranial hemorrhage, active pathological bleeding, severe hepatic impairment);
- major periprocedural complications;
- Glomerular filtration rate \< 30 ml/min or requiring haemodialysis;
- Non-sinus rhythm;
- severe chronic obstructive pulmonary disease;
- requirement for oral anticoagulant;
- risk of bleeding or bradycardic events;
- Ejection fraction \< 45%;
- Cardiogenic shock;
- Severe left ventricular hypertrophy;
- severe valvular disease;
- indication to coronary artery bypass grafting;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massimo Mancone
Rome, Rome, 00100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 18, 2013
First Posted
January 10, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Last Updated
January 10, 2014
Record last verified: 2014-01