Αρχική Multicentre Studies

Multicentre Studies

The following multicentre trials are currently active in the Cardiology Department of the Democritus University:

 

1) Effect of Οtamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy (TAO)

Randomized, double-blind, triple-dummy trial to compare the efficacy of otamixaban with unfractionated heparin + eptifibatide, in patients with unstable angina / non-ST-segment elevation myocardial infarction scheduled to undergo an early invasive strategy.

Sponsor: Sanofi Aventis

ClinicalTrials.gov Identifier: NCT01076764

Status: Recruiting

Local principal investigator: Prof. S. Konstantinides

 

2) Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction (STREAM)

In patients with acute ST-elevation myocardial infarction randomized within 3 hours of onset of symptoms, the efficacy and safety of a strategy of early fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterization within 6-24 hours, or rescue coronary intervention as required, is compared to a strategy of primary PCI according to established local standards.

Sponsor: Boehringer Ingelheim

ClinicalTrials.gov Identifier: NCT00623623

Status: Recruiting

Local principal investigator: Prof. S. Konstantinides

3) Pulmonary Embolism Thrombolysis Study (PEITHO)

A prospective, randomised, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction.

Sponsor: Assistance Publique d’ Hôpitaux de Paris

ClinicalTrials.gov Identifier: NCT00639743

Status: Recruiting

Local principal investigator: Prof. S. Konstantinides

4) A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment (ΑRTEMIS AF Loading)

A randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone treatment after conversion with loading dose of amiodarone in patients with persistent atrial fibrillation requiring conversion of AF.

Sponsor: Assistance Publique d’ Hôpitaux de Paris

ClinicalTrials.gov Identifier: NCT 01199081

Status: Initiation pending

Local principal investigator: Ass. Prof. D. Stakos

 

5) The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy (STABILITY)

A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)Trial.

Sponsor: GlaxoSmithKline 

ClinicalTrials.gov Identifier: NCT00799903

Status: Recruitment completed – Follow up ongoing

Local principal investigator:  Prof. D. Tziakas

 

6) Study assessInG the morbi-mortality beNefits of the If inhibitorivabradine in patients with coronary arterY disease (SIGNIFY)

Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.

Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.) 

ClinicalTrials.gov Identifier: CL3-16257-083

Status: Recruiting

Local principal investigator: Prof. D. Tziakas

 

 

The following multicentre studies have recently been completed under the participation of the Cardiology Department of the Democritus University:

1) Randomized Evaluation of Long Term Anticoagulant Therapy With Dabigatran Etexilate (RE-LY) 

Randomized evaluation of long-term anticoagulant therapy comparing the efficacy and safety of two blinded doses of Dabigatran etexilate with open-label Warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non inferiority trial.

Sponsor: Boehringer Ingelheim

ClinicalTrials.gov Identifier: NCT00262600

Status: Terminated 2008 and published

Local principal investigator: Prof. D. Tziakas

Dabigatran versus warfarin in patients with atrial fibrillation.

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. N Engl J Med 2009;361:1139-51.

2) The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction

Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-Year Randomised Double-Blind Placebo-Controlled International Multicentre Study.

Sponsor: Institut De Recherche International Servier

ClinicalTrials.gov Identifier: NCT00143507

Status: Terminated (2008) and published

Local principal investigator:  Prof. D. Tziakas

3) Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT)

A study to assess if Heart Rate reduction by direct sinus node inhibition can decrease cardiovascular outcomes in patients with chronic heart failure (CHF) and left ventricular systolic dysfunction (LVD).

Sponsor: Institut De Recherche International Servier

Registration number: ISRCTN70429960

Status: Terminated 2010 and published

Local principal investigator: Ass.Prof. D. Stakos

Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo controlled study.

Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Lancet 2010;376:875-85.

 

 

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Κατασκευή Ιστοσελίδας Πανεπιστημιακή Καρδιολογική Κλινική 2010 | Επικοινωνία | Αρχική