- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01283282
Investigation of the Athero-Protective Effects of Clopidogrel (APECS)
15 avril 2015 mis à jour par: Arshed A. Quyyumi, Emory University
Phase 4 Study of Clopidogrel in Patients With Stable Coronary Artery Disease to Determine Effects on Vascular Function, Biomarkers and Endothelial Progrenitor Cells
The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels.
The investigators will give half of the patients clopidogrel and the other half a sugar pill, placebo, and check the levels of these markers and helpful cells in each group.
At the same time the investigators will check how well these patient's blood vessels work using ultrasound imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's blood vessels are.
After 6 weeks of drug therapy, the patients will switch to the other drug and these same tests will be performed after an additional 6 weeks of therapy.
The drug taken by the patient will not be known to the patient or the researchers.
The patients will continue on their prescribed medical therapy during the duration of the 12 week study.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Blockages in the blood vessels of the heart are caused by atherosclerosis.
Atherosclerosis is the main cause for chest pain and heart attacks.
Gradual narrowing of the vessels of the heart caused by blockages causes chronic symptoms, such as chest pain.
Those with these findings often have a cardiac catheterization to detect these blockages.
Additionally these patients may have an angioplasty or stent placed to help relieve these symptoms.
With this angioplasty/stent procedure, patients are placed on the drug clopidogrel to help prevent clots from forming and narrowing of the blood vessels.
Clopidogrel is a blood thinner that prevents clots from forming similar to an aspirin, but is more powerful and effective.
Markers, or substances, have been identified that cause worsening of the blockages in the blood vessels of the heart.
Many of these substances have been shown to decrease with the use of clopidogrel.
This occurs separately from clopidogrel's ability to prevent clots.
Endothelial progenitor cells, or EPCs, come mostly from the bone marrow and is helpful in repairing damage to the lining of the blood vessels of the heart.
The EPCs help balance out the damage incurred in the blood vessels from those harmful markers.
Several other drugs commonly used in heart disease have recently been shown to improve EPCs function.
With this in mind, it is important to understand more of clopidogrel's function.
A decrease in markers that cause worsening of the blockages, and an increase in the number of cells that will help repair damaged blood vessels of the heart is important in avoiding future chest pain and heart attacks.
This may be how clopidogrel is currently protecting patients from developing new blockages.
The investigators would like to investigate whether clopidogrel will help lower the level of harmful markers in patients with coronary artery disease, and at the same time will help increase the cells that are useful in repairing the damaged blood vessels.
The investigators will give half of the patients clopidogrel and the other half a sugar pill, placebo, and check the levels of these markers and helpful cells in each group.
At the same time the investigators will check how well these patient's blood vessels work using ultrasound imaging of the forearm to see how blood vessels relax and tonometry to see how stiff the patient's blood vessels are.
After 6 weeks of drug therapy, the patients will switch to the other drug and these same tests will be performed after an additional 6 weeks of therapy.
The drug taken by the patient will not be known to the patient or the researchers.
The patients will continue on their prescribed medical therapy during the duration of the 12 week study.
Type d'étude
Interventionnel
Inscription (Réel)
48
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Male or females without child bearing potential aged 21-80 years
- Known coronary artery disease by angiogram or documented myocardial infarction.
- Able to provide written informed consent
Exclusion Criteria:
- Treated with clopidogrel or ticlodipine in the previous 3 months
- Age < 21 or >80 years
- Premenopausal females with potential for pregnancy
- Allergy to clopidogrel or aspirin
- Initiation or change in dose of any concomitant medical therapy within 2 months before the study
- Uncontrolled hypertension with BP>180 mmHg systolic and >120 mmHg diastolic
- Treated with coumadin therapy
- Intolerance or allergy to statins
- Acute infection in previous 4 weeks
- History of substance abuse
- Uninterpretable PAT test
- Current neoplasm
- Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X normal)
- Acute coronary syndrome, heart failure, CVA, coronary intervention within 3 months
- Known aortic stenosis, hypertrophic cardiomyopathy, symptomatic heart failure.
- Inability to give informed consent
- Inability to return to Emory for follow-up
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Clopidogrel/Placebo
Subjects were randomized to clopidogrel 75 mg daily for 6 weeks.
Then immediately transitioned to a placebo daily for 6 weeks.
|
Clopidogrel 75 mg PO qday for 6 weeks
Autres noms:
Placebo PO qday for 6 weeks
|
Comparateur actif: Placebo/Clopidogrel
Subjects were randomized to a placebo daily for 6 weeks.
Then immediately transitioned to clopidogrel 75 mg daily for 6 weeks.
|
Clopidogrel 75 mg PO qday for 6 weeks
Autres noms:
Placebo PO qday for 6 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Flow-mediated Dilation (FMD)
Délai: Baseline, Week 12
|
Flow-mediated dilation (FMD) collected by an ultrasound and is measured by the percent change in diameter of the brachial artery from baseline to 12 weeks.
|
Baseline, Week 12
|
Nitroglycerin-mediated Vasodilation
Délai: Baseline, Week 12
|
Nitroglycerin (NTG)-mediated vasodilation was measured after 0.4 mg of NTG was administered sublingually.
Brachial artery images were obtained via ultrasound after three minutes of NTG administration.
Measurements from the twelve frames will be averaged to calculate the percent change in diameter of the brachial artery from baseline to 12 weeks.
|
Baseline, Week 12
|
Endothelial Progenitor Cells (EPCs)
Délai: Week 12
|
The circulating progenitor-enriched population of cells was measured by the expression of surface antigens using direct flow cytometry for CD34+, CD34+/CD133+, CD34+/ VEGF2R+ and CD34+/CD133+/VEGF2R+
|
Week 12
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pulse Wave Velocity (PWV)
Délai: Week 12
|
PWV was measured between the carotid and femoral arteries using the SphygmoCor device.
Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating.
Velocity (distance per time in seconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.
|
Week 12
|
Oxidative Stress Markers
Délai: Week 12
|
Oxidative stress was measured by using liquid chromatography to collect plasma cystine, cysteine, gluthione, and oxidized glutathione levels.
|
Week 12
|
Inflammatory Marker High-sensitivity C-reactive Protein (hsCRP)
Délai: Week 12
|
High-sensitivity C-reactive protein (hsCRP) was measured.
The hsCRP levels were measured by Dade Behring nephelometry.
|
Week 12
|
Inflammatory Marker CD40 Ligand
Délai: Week 12
|
CD40 ligand levels were measured.
The level of CD40 ligand were measured using the Flurokine MultiAnalyte profiling (MAP) Human Base Kit B.
|
Week 12
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ziyad Ghazzal, MD, American University of Beirut, Emory University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2008
Achèvement primaire (Réel)
1 décembre 2010
Achèvement de l'étude (Réel)
1 décembre 2010
Dates d'inscription aux études
Première soumission
24 janvier 2011
Première soumission répondant aux critères de contrôle qualité
24 janvier 2011
Première publication (Estimation)
25 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 mai 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 avril 2015
Dernière vérification
1 avril 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiaques
- Maladies cardiovasculaires
- Maladies vasculaires
- Artériosclérose
- Maladies artérielles occlusives
- Maladie de l'artère coronaire
- Ischémie myocardique
- Maladie coronarienne
- 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
- Clopidogrel
Autres numéros d'identification d'étude
- IRB00005145
- APECS (Autre identifiant: Other)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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