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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

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ClinicalTrials.gov Identifier: NCT02032290
Recruitment Status : Unknown
Verified January 2014 by Massimo Mancone, Azienda Policlinico Umberto I.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Massimo Mancone, Azienda Policlinico Umberto I

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome: Non ST Elevation Myocardial Infarction ST Elevation Myocardial Infarction Unstable Angina Procedure: Assessment of Coronary Flow Reserve Procedure: Percutaneous coronary intervention Drug: ticagrelor loading Drug: Clopidogrel loading Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : February 2014
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ticagrelor
ticagrelor: loading dose of 180 mg and maintaining dose of 90 mg twice daily in NSTEMI and STEMI (Class I B) patients;
Procedure: Assessment of Coronary Flow Reserve
Procedure: Percutaneous coronary intervention
Drug: ticagrelor loading
Active Comparator: clopidogrel
clopidogrel: loading dose of 600 mg and maintaining dose of 75 mg daily in NSTEMI (Class I B) and STEMI (Class I C) patients.
Procedure: Assessment of Coronary Flow Reserve
Procedure: Percutaneous coronary intervention
Drug: Clopidogrel loading



Primary Outcome Measures :
  1. assessment of coronary flow reserve [ Time Frame: 2 hours after the loading dose of drugs. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032290


Contacts
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Contact: massimo mancone, PhD 00390649979044 massimomancone@gmail.com

Locations
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Italy
Massimo Mancone
Rome, Italy, 00100
Contact    00390649970468      
Principal Investigator: massimo mancone, PhD         
Sponsors and Collaborators
Azienda Policlinico Umberto I

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Responsible Party: Massimo Mancone, PhD, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT02032290    
Other Study ID Numbers: Ticagrelor - Clopidogrel
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Angina, Unstable
Non-ST Elevated Myocardial Infarction
Syndrome
Infarction
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs