- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02798874
Effects of Ticagrelor on No-reflow in Patients With Acute ST-segment Elevation Myocardial Infarction
Chinese People's Liberation Army General Hospital
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Investigators enrolled 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between September 2013 and March 2015. STEMI was defined as typical chest pain lasting N30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T. We screen high-risk patients through no-reflow risk prediction model, patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. We randomly assigned eligible patients in a 1:1 ratio to receive either ticagrelor 180 mg or clopidogrel 600 mg 30 min before PCI.
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure. Secondary efficacy variables were troponin T (TnT), high sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), superoxide dismutase (SOD), malondialdehyde (MDA), endothelin-1 (ET-1), and nitric oxide (NO) level
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Beijing
-
Peking, Beijing, Chine, 100853
- Chinese People's Liberation Army General Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients with STEMI who were admitted to the Chinese PLA General Hospital
Exclusion Criteria:
- 1.unconscious at presentation; 2.had cardiogenic shock, 3.hypoglycemia, 4.diabetic ketoacidosis; 5.had a history of myocardial infarction, stent thrombosis, or renal insufficiency; 6.had previously undergone coronary artery bypass surgery.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Ticagrelor Group
ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery
|
ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery
|
Comparateur actif: Clopidogrel Group
Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery
|
Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
the prevalence of no-reflow,
Délai: immediately post procedure
|
Anterograde coronary flow in the infarct-related artery was graded according to the thrombolysis in myocardial infarction (TIMI) grading system
|
immediately post procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
main cardiovascular events
Délai: 90 days
|
bleeding, dialysis, myocardial infarction, heart failure and all-cause death
|
90 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Dai Yun Chen, MD, Chinese PLA General Hospital
Publications et liens utiles
Publications générales
- Brosh D, Assali AR, Mager A, Porter A, Hasdai D, Teplitsky I, Rechavia E, Fuchs S, Battler A, Kornowski R. Effect of no-reflow during primary percutaneous coronary intervention for acute myocardial infarction on six-month mortality. Am J Cardiol. 2007 Feb 15;99(4):442-5. doi: 10.1016/j.amjcard.2006.08.054. Epub 2006 Dec 20.
- Bolognese L, Carrabba N, Parodi G, Santoro GM, Buonamici P, Cerisano G, Antoniucci D. Impact of microvascular dysfunction on left ventricular remodeling and long-term clinical outcome after primary coronary angioplasty for acute myocardial infarction. Circulation. 2004 Mar 9;109(9):1121-6. doi: 10.1161/01.CIR.0000118496.44135.A7. Epub 2004 Feb 16.
- Reffelmann T, Kloner RA. The no-reflow phenomenon: A basic mechanism of myocardial ischemia and reperfusion. Basic Res Cardiol. 2006 Sep;101(5):359-72. doi: 10.1007/s00395-006-0615-2.
- Jogiya R, Kozerke S, Morton G, De Silva K, Redwood S, Perera D, Nagel E, Plein S. Validation of dynamic 3-dimensional whole heart magnetic resonance myocardial perfusion imaging against fractional flow reserve for the detection of significant coronary artery disease. J Am Coll Cardiol. 2012 Aug 21;60(8):756-65. doi: 10.1016/j.jacc.2012.02.075. Epub 2012 Jul 18.
- Wittfeldt A, Emanuelsson H, Brandrup-Wognsen G, van Giezen JJ, Jonasson J, Nylander S, Gan LM. Ticagrelor enhances adenosine-induced coronary vasodilatory responses in humans. J Am Coll Cardiol. 2013 Feb 19;61(7):723-7. doi: 10.1016/j.jacc.2012.11.032. Epub 2013 Jan 9.
- Rezkalla SH, Kloner RA. Coronary no-reflow phenomenon: from the experimental laboratory to the cardiac catheterization laboratory. Catheter Cardiovasc Interv. 2008 Dec 1;72(7):950-7. doi: 10.1002/ccd.21715.
- Steg PG, James S, Harrington RA, Ardissino D, Becker RC, Cannon CP, Emanuelsson H, Finkelstein A, Husted S, Katus H, Kilhamn J, Olofsson S, Storey RF, Weaver WD, Wallentin L; PLATO Study Group. Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis. Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.
- Wang JW, Chen YD, Wang CH, Yang XC, Zhu XL, Zhou ZQ. Development and validation of a clinical risk score predicting the no-reflow phenomenon in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Cardiology. 2013;124(3):153-60. doi: 10.1159/000346386. Epub 2013 Mar 8.
- Chen Y, Wang C, Yang X, Wang L, Sun Z, Liu H, Chen L. Independent no-reflow predictors in female patients with ST-elevation acute myocardial infarction treated with primary percutaneous coronary intervention. Heart Vessels. 2012 May;27(3):243-9. doi: 10.1007/s00380-011-0144-2. Epub 2011 Apr 28.
- Wang J, Chen YD, Zhi G, Xu Y, Chen L, Liu HB, Zhou X, Tian F. Beneficial effect of adenosine on myocardial perfusion in patients treated with primary percutaneous coronary intervention for acute myocardial infarction. Clin Exp Pharmacol Physiol. 2012 Mar;39(3):247-52. doi: 10.1111/j.1440-1681.2012.05668.x.
- Teng R, Oliver S, Hayes MA, Butler K. Absorption, distribution, metabolism, and excretion of ticagrelor in healthy subjects. Drug Metab Dispos. 2010 Sep;38(9):1514-21. doi: 10.1124/dmd.110.032250. Epub 2010 Jun 15.
- Wang CH, Chen YD, Yang XC, Wang LF, Wang HS, Sun ZJ, Liu HB. A no-reflow prediction model in patients with ST-elevation acute myocardial infarction and primary drug-eluting stenting. Scand Cardiovasc J. 2011 Apr;45(2):98-104. doi: 10.3109/14017431.2011.558209. Epub 2011 Feb 17.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de l'agrégation plaquettaire
- Antagonistes des récepteurs purinergiques P2Y
- Antagonistes des récepteurs purinergiques P2
- Antagonistes purinergiques
- Agents purinergiques
- Ticagrélor
- Clopidogrel
Autres numéros d'identification d'étude
- 16qgyyq
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