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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

Primary Purpose

Acute Coronary Syndrome:, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Assessment of Coronary Flow Reserve
Percutaneous coronary intervention
ticagrelor loading
Clopidogrel loading
Sponsored by
Azienda Policlinico Umberto I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Coronary Syndrome:

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with acute coronary syndromes undergoing Percutaneous Coronary Intervention with stent implantation;
  • Patients ≥ 18 and ≤ 75 years old.
  • Signed informed consent;

Exclusion Criteria:

  • 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;
  • diffuse coronary atherosclerosis;

Sites / Locations

  • Massimo Mancone

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ticagrelor

clopidogrel

Arm Description

ticagrelor: loading dose of 180 mg and maintaining dose of 90 mg twice daily in NSTEMI and STEMI (Class I B) patients;

clopidogrel: loading dose of 600 mg and maintaining dose of 75 mg daily in NSTEMI (Class I B) and STEMI (Class I C) patients.

Outcomes

Primary Outcome Measures

assessment of coronary flow reserve

Secondary Outcome Measures

Full Information

First Posted
December 18, 2013
Last Updated
January 8, 2014
Sponsor
Azienda Policlinico Umberto I
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1. Study Identification

Unique Protocol Identification Number
NCT02032290
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Policlinico Umberto I

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome:, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ticagrelor
Arm Type
Active Comparator
Arm Description
ticagrelor: loading dose of 180 mg and maintaining dose of 90 mg twice daily in NSTEMI and STEMI (Class I B) patients;
Arm Title
clopidogrel
Arm Type
Active Comparator
Arm Description
clopidogrel: loading dose of 600 mg and maintaining dose of 75 mg daily in NSTEMI (Class I B) and STEMI (Class I C) patients.
Intervention Type
Procedure
Intervention Name(s)
Assessment of Coronary Flow Reserve
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Type
Drug
Intervention Name(s)
ticagrelor loading
Intervention Type
Drug
Intervention Name(s)
Clopidogrel loading
Primary Outcome Measure Information:
Title
assessment of coronary flow reserve
Time Frame
2 hours after the loading dose of drugs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with acute coronary syndromes undergoing Percutaneous Coronary Intervention with stent implantation; Patients ≥ 18 and ≤ 75 years old. Signed informed consent; Exclusion Criteria: 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; diffuse coronary atherosclerosis;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
massimo mancone, PhD
Phone
00390649979044
Email
massimomancone@gmail.com
Facility Information:
Facility Name
Massimo Mancone
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Contact:
Phone
00390649970468
First Name & Middle Initial & Last Name & Degree
massimo mancone, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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