- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217447
Assessment of Quitting Versus Using Aspirin Therapy In Patients Treated With Oral Anticoagulation for Atrial Fibrillation or Other Indication With Stabilized Coronary Artery Disease (AQUATIC)
- Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A).
- Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A).
- During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing.
- At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD.
- However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice.
- The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events.
- The coordinating investigators therefore designed a double blind placebo controlled trial in order to assess the optimal antithrombotic regimen that should be pursued long-life in this subset of patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A).
- Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A).
- During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing.
- At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD.
- However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice.
- The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events.
AQUATIC is a prospective, randomized, double-blind, placebo controlled, parallel-group, multi-center study.
Randomization into 2 treatment groups and stratified on study center, type of OAC (VKA vs. DOAC), antithrombotic treatment received at the time of inclusion (dual therapy combining single antiplatelet therapy + OAC vs. OAC alone).
Experimental group : Patients intaking full-dose OAC + ASA 100mg od.
Control group : Patients intaking full-dose OAC + Placebo of ASA 100mg od.
Note:
- For Apixaban: in case of > 1 of the followings: > 80 years old, weight < 60kg, creatinine level > 133μmol/l; Or a creatinine clearance between 30 and 50 ml/min (Cockroft Formula), the dose of Apixaban will be reduced to 2.5 mg bid.
- For Rivaroxaban: in case of moderate creatinine clearance (Cockroft Formula) (between 30 and 50 ml/min) or severe renal insufficiency (between 15 and 29 ml/min) the dose of Rivaroxaban will be reduced to 15 mg od.
- For Dabigatran: in case of moderate creatinine clearance (Cockroft Formula) (between 30 and 50 ml/min) with age between 75 and 80 years: the dose of Dabigatran will be 150 mg bid or 110 mg bid, according to the ischemic and hemorrhagic risk of the patient. In case of age > 80 years and/or concomitant administration of Verapamil, the dose of Dabigatran will be reduced to 110 mg bid.
- For VKA: target INR (International Normalised Ratio) between 2 and 3.
The primary efficacy objective is to demonstrate, in high-risk stabilized patients after PCI requiring also anticoagulation for AF, the superiority of the dual therapy ASA 100mg od + full-dose of OAC for 24-48 months versus full-dose of OAC alone (+ placebo) on a composite endpoint associating: cardio-vascular (CV) mortality, myocardial infarction, stroke, coronary revascularization, systemic embolism, and acute limb ischemia.
The primary safety objective is major bleeding (ISTH : International Society of Thrombosis and Haemostasis).
The secondary efficacy objectives are evaluation of efficacy of dual therapy SA 100mg od + OAC full ose versus OAC alone (+placebo) for:
- The composite of CV mortality, MI (Myocardial Infarction ), stroke
- CV mortality
- All cause death
- Myocardial infarction (MI)
- Stent thrombosis (definite or probable)
- Stroke (ischemic, hemorrhagic, or stroke of uncertain cause, transient ischemic attack [TIA])
- Coronary revascularization
- Systemic embolism
- Acute limb ischemia
Net clinical benefit:
- All cause mortality
- Major bleeding [define according to the International Society of Thrombosis and Haemostasis (ISTH): an acute, linically overt bleeding accompanied by one or more of the following findings: 2g/dl decline in Hemoglobin level r = 2 red blood cell transfusions over a 24-hour period, leeding of a major organ (intracranial, intramedullary, intraocular, pericardial, interarticular, intramuscular and / or retro peritoneal) or fatal bleeding]
Thrombotic cardiovascular events:
- Myocardial infarction
- Stent thrombosis
- Stroke (ischemic, hemorrhagic, or stroke of uncertain cause, TIA)
- Any coronary revascularization
- Systemic embolism
- Acute limb ischemia
The secondary safety objectives are :
- Major and clinically relevant non major bleeding (ISTH)
- Major bleeding (TIMI : Thrombolysis In Myocardial Infarction)
- Major bleeding (BARC ≥3 : Bleeding Academic Research Consortium)
All the included patients will be randomized at visit 1 and followed every 6 months until death or the end of the study (i.e. achievement of 2-year follow-up of the last included patient, maximum of 48 month followup for the first included patient).The first patient may require up to 9 visits .
2000 patients are expected to be included.
Inclusion period : 72 months. Duration of patient's participation: 24 to 48 months depending of time of inclusion.
Total study duration: 48 months.
All included patients will remain in the study until death or the end of the trial (i.e. achievement of 2-year follow-up of the last included patient).
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Martine GILARD, PhD
- Phone Number: +33 2 98 34 75 03
- Email: martine.gilard@chu-brest.fr
Study Contact Backup
- Name: Marie DURANTI
- Email: marie.duranti@chu-brest.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHRU d'Amiens
-
Contact:
- Laurent LEBORGNE, PUPH
- Email: leborgnelaurent@chu-amiens.fr
-
Angers, France, 49933
- Recruiting
- CHU d'Angers
-
Contact:
- Alain FURBER, PU
- Email: alfurber@chu-angers.fr
-
Annecy, France, 74370
- Recruiting
- CH d'Annecy-Genevois
-
Contact:
- Loic BELLE, PU
- Email: loic.belle@wanadoo.fr
-
Antibes, France, 06606
- Recruiting
- CH d'Antibes
-
Contact:
- Anne BELLEMAIN-APPAIX, PU
- Email: anne.bellemain-appaix@ch-antibes.fr
-
Antony, France, 92160
- Recruiting
- Hopital Prive d'Antony
-
Contact:
- Patrick DUPOUY, PU
- Email: pdupouy@club-internet.fr
-
Arras, France, 62000
- Recruiting
- CH d'Arras
-
Contact:
- Damien BROUCQSAULT, PU
- Email: damien.broucqsault@gh-artoisternois.fr
-
Avignon, France, 84902
- Recruiting
- CH d'Avignon
-
Contact:
- Michel PANSIERI, PU
- Email: mpansieri@ch-avignon.fr
-
Bayonne, France, 64100
- Recruiting
- CH de la Côte Basque - Bayonne
-
Contact:
- Jean Noel LABEQUE, PU
- Email: dr.jnlabeque@gmail.com
-
Bordeaux, France, 33604
- Recruiting
- Hôpital Haut Lévêque -CHU Bordeaux-Pessac
-
Contact:
- Pierre COSTE, PUPH
- Email: pierre.coste@chu-bordeaux.fr
-
Brest, France, 29609
- Recruiting
- CHU de Brest
-
Contact:
- Romain DIDIER, PH
- Email: romain.didier@chu-brest.fr
-
Contact:
- Charlotte LAOT
- Email: charlotte.laot@chu-brest.fr
-
Bron, France, 69677
- Recruiting
- Hôpital Louis Pradel - Bron
-
Contact:
- François DERIMAY, PU
- Email: fderimay@hotmail.fr
-
Cannes, France, 06414
- Recruiting
- CH Pierre Nouveau -Cannes
-
Contact:
- Gilles ZEMOUR, PU
- Email: g.zemour@ch-cannes.fr
-
Cergy-Pontoise, France, 95301
- Recruiting
- Centre Hospitalier René Dubos - Cergy Pontoise
-
Contact:
- Véronique DECALF, PU
- Email: veronique.decalf@ght-novo.fr
-
Chalon-sur-Saône, France, 71100
- Recruiting
- CH Chalon sur Saône
-
Contact:
- Maxime FAYARD, PU
- Email: maxime.fayard@ch-chalon71.fr
-
Chartres, France, 28630
- Recruiting
- CH Louis Pasteur - Chartres - Le Coudray
-
Contact:
- Grégoire RANGE, PU
- Email: grange@ch-chartres.fr
-
Clermont-Ferrand, France, 63000
- Recruiting
- CHU de Clermont-Ferrand
-
Contact:
- Pascal MOTREFF, PUPH
- Email: pmotreff@chu-clermontferrand.fr
-
Compiègne, France, 60200
- Recruiting
- CH Compiègne
-
Contact:
- Jérôme CLERC, PU
- Email: j.clerc@ch-compiègnenoyon.fr
-
Corbeil-Essonnes, France, 91106
- Recruiting
- CH Sud Francilien Corbeil-Essonnes
-
Contact:
- Pascal GOUBE
- Email: pascal.goube@ch-sud-francilien.fr
-
Créteil, France, 94000
- Recruiting
- Hôpital Henri Mondor - Créteil
-
Contact:
- Romain GALLET, PU
- Email: romain.gallet@aphp.fr
-
Dijon, France, 21000
- Recruiting
- CHU de Dijon
-
Contact:
- Yves COTTIN, PUPH
- Email: yves.cottin@chu-dijon.fr
-
Grenoble, France, 38043
- Recruiting
- CHU de GRENOBLE
-
Contact:
- Gerald VANZETTO, PUPH
- Email: GVanzetto@chu-grenoble.fr
-
Grenoble, France, 38028
- Recruiting
- GHM - Grenoble
-
Contact:
- Damien GUIJARRO, PU
- Email: d.guijarro@ghm-grenoble.fr
-
Haguenau, France, 67504
- Not yet recruiting
- CH Haguenau
-
Contact:
- Sabrina UHRY, PU
- Email: sabrina.uhry@ch-haguenau.fr
-
La Réunion, France, 97400
- Recruiting
- Clinique St Clothilde -La Réunion
-
Contact:
- Lucas MORLON, PU
- Email: lucasmorlon@gmail.com
-
Lens, France, 62300
- Recruiting
- CH de Lens
-
Contact:
- Hugo VERHEYDE, PU
- Email: mebouviez@ch-lens.fr
-
Lille, France, 59037
- Recruiting
- CHRU de Lille
-
Contact:
- Gilles LEMESLE, PUPH
- Email: Gilles.LEMESLE@CHRU-LILLE.FR
-
Limoges, France, 87042
- Recruiting
- CHU de Limoges
-
Contact:
- Victor ABOYANS, PUPH
- Email: victor.aboyans@chu-limoges.fr
-
Lyon, France, 69007
- Recruiting
- CH St Joseph-St Luc Lyon
-
Contact:
- Olivier DUBREUIL, PU
- Email: odubreuil@chsjsl.fr
-
Marseille, France, 13015
- Recruiting
- Marseille-Hôpital Nord
-
Contact:
- Laurent BONELLO, PUPH
- Email: laurent.bonello@ap-hm.fr
-
Marseille, France, 13385
- Recruiting
- Marseille- Hôpital La Timone
-
Contact:
- Thomas CUISSET, PUPH
- Email: thomas.cuisset@mail.ap-hm.fr
-
Martigues, France
- Recruiting
- CH Martigues
-
Contact:
- Serge YVORRA, PU
- Email: serge.yvorra@ch-martigues.fr
-
Melun, France, 77000
- Recruiting
- Clinique Les Fontaines - Melun
-
Contact:
- Eduardo APTECAR, PU
- Email: eaptecar@club-internet.fr
-
Metz, France, 57085
- Withdrawn
- CHR de Metz
-
Montfermeil, France, 93370
- Withdrawn
- GHI Le Raincy-Montfermeil
-
Montpellier, France, 24298
- Recruiting
- CHU de Montpellier
-
Contact:
- Florence LECLERCQ, PUPH
- Email: f-leclercq@chu-montpellier.fr
-
Montpellier, France, 34000
- Recruiting
- Clinique du Millénaire - Montpellier
-
Contact:
- Christophe PIOT, PUPH
- Email: scpcardio@gmail.com
-
Nîmes, France, 30000
- Recruiting
- Chu de Nimes
-
Contact:
- Guillaume CAYLA, PUPH
- Email: guillaume.cayla@chu-nimes.fr
-
Orléans, France, 45067
- Recruiting
- CHR d'Orléans
-
Contact:
- Marc GORALSKI, PU
- Email: marc.goralski@chr-orleans.fr
-
Paris, France, 75010
- Recruiting
- Paris-Lariboisière
-
Contact:
- Jean-Guillaume DILLINGER, PU
- Email: jean-guillaume.dillinger@aphp.fr
-
Paris, France, 75012
- Recruiting
- Paris-St Antoine
-
Contact:
- Franck BOCCARA, PUPH
- Email: franck.boccara@sat.aphp.fr
-
Paris, France, 75013
- Recruiting
- Paris-Pitié-Salpêtrière
-
Contact:
- Mathieu KERNEIS, PU
- Email: mathieu.kerneis@bidmc.harvard.edu
-
Paris, France, 75015
- Recruiting
- Paris-HEGP Cardiologie
-
Contact:
- Etienne PUYMIRAT, PU
- Email: etienne.puymirat@egp.aphp.fr
-
Paris, France, 75015
- Recruiting
- Paris-HEGP Médecine vasculaire
-
Contact:
- Emmanuel MESSAS, PUPH
- Email: emmanuel.messas@aphp.fr
-
Paris, France, 75877
- Recruiting
- Paris-Bichat
-
Contact:
- Grégory DUCROCQ, PUPH
- Email: gregory.ducrocq@aphp.fr
-
Pau, France, 64000
- Recruiting
- CH de Pau
-
Contact:
- Nicolas DELARCHE, PU
- Email: N.Delarche@wanadoo.fr
-
Poitiers, France, 86021
- Recruiting
- CHU de Poitiers
-
Contact:
- Claire BOULETI, PUPH
- Email: claire.bouleti@chu-poitiers.fr
-
Périgueux, France, 24000
- Recruiting
- Ch Perigueux
-
Contact:
- Sandrine GOUGNOT, PU
- Email: sandrine.gougnot@ch-perigueux.fr
-
Rennes, France, 35033
- Recruiting
- CHU de Rennes
-
Contact:
- Hervé LEBRETON, PUPH
- Email: herve.le.breton@chu-rennes.fr
-
Rouen, France, 76031
- Recruiting
- Chu de Rouen
-
Contact:
- Eric DURAND, PUPH
- Email: eric.durand@chu-rouen.fr
-
Rouen, France, 76000
- Recruiting
- Clinique St Hilaire - Rouen
-
Contact:
- Matthieu GODIN, PU
- Email: mgodin@clinique-sainthilaire.fr
-
Seclin, France, 59113
- Recruiting
- CH de Seclin
-
Contact:
- Alessandro COSENZA, PU
- Email: alessandro.cosenza@ghsc.fr
-
Strasbourg, France, 67000
- Recruiting
- Clinique Rhena - Strasbourg
-
Contact:
- Nicolas LHOEST, PU
- Email: scpcardio@noos.fr
-
Strasbourg, France, 67091
- Recruiting
- CHU de Strasbourg
-
Contact:
- Patrick OHLMANN, PUPH
- Email: patrick.ohlmann@chru-strasbourg.fr
-
Toulouse, France, 31059
- Recruiting
- CHU de Toulouse
-
Contact:
- Thibault LHERMUSIER, PU
- Email: lhermusier.t@chu-toulouse.fr
-
Toulouse, France, 31076
- Recruiting
- Clinique Pasteur-Toulouse
-
Contact:
- Antoine SAUGUET, PU
- Email: a.sauguet@clinique-pasteur.com
-
Tours, France, 37170
- Recruiting
- CHRU de Tours
-
Contact:
- Denis ANGOULVANT, PUPH
- Email: d.angoulvant@chu-tours.fr
-
Vandœuvre-lès-Nancy, France, 54500
- Recruiting
- CHU de Nancy - Hopitaux de Brabois
-
Contact:
- Batric POPOVIC, PU
- Email: b.popovic@chru-nancy.fr
-
Versailles, France, 78153
- Recruiting
- Hôpital André Mignot - CH de Versailles
-
Contact:
- Jean Louis GEORGES, PU
- Email: j.georges@ch-versailles.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients >18 year-old
- All patients that need anticoagulation with direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA) for AF (paroxysmal, persistent or permanent) or other indication and have a stabilized CAD (free from MI, or coronary revascularization in the past year) but remain at high residual risk of recurrent coronary and vascular events. The use of DOAC will be promoted as recommended by guidelines.
- Two different categories of patients could be included in the study, i) patients treated at the time of inclusion with the association of OAC and single antiplatelet therapy, it will be tested for them aspirin vs. interruption of antiplatelet therapy ii) patients treated with OAC alone at the time of inclusion, it will be tested for them administration of aspirin vs. no additional treatment with aspirin.
High-risk of coronary and vascular event is defined as follow :
- History of PCI during an ACS involving placement of ≥1 stent(s) since >6 months.
- History of PCI (>6 months) outside the context of ACS but with high-risk features of ischemic event recurrences defined as: diabetes, or diffuse multivessel disease (defined by the involvement of the 3 coronary vessels), or chronic kidney disease (creatinine clearance < 50ml/min), or prior stent thrombosis, or complex PCI (defined by: stenting of the last remaining patent coronary artery, left main, at least 3 stents implanted and/or 3 lesions treated, bifurcation with two stents, length of stent >60mm and chronic total coronary occlusion) or the presence of peripheral artery disease (previous limb revascularization bypass or percutaneous angioplasty, previous limb or foot amputation for arterial vascular disease, history of intermittent claudication of peripheral artery stenosis (≥50%) ,previous carotid revascularization or carotid stenosis ≥50%).
Women of childbearing potential with effective contraception defined as
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation :
- oral
- intravaginal
- transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation :
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
Exclusion Criteria:
- Any coronary event within 6 months prior to randomization
- High risk of bleeding defined as recent (≤6 months) ISTH major bleeding event
- Constitutional or acquired haemorrhagic disease including gastrointestinal bleeding and thrombocytopenia
- Planned PCI within the next 6 months after randomization or subject requiring P2Y12 receptor antagonist therapy
- Stroke within 1 month or any history of hemorrhagic stroke
- Any contraindication to aspirin (ASA) or any of these excipients or other NSAIDs (hypersensitivity, allergy, active bleeding)
- Any contraindication to anticoagulant
- History (s) of asthma induced by the administration of salicylates or substances of close activity (especially NSAIDs)
- Evolutionary gastroduodenal ulcer
- Any other gastroduodenal history
- Severe renal insufficiency
- Severe hepatic insufficiency
- Severe, uncontrolled heart failure
- Lactose intolerance
- Pregnancy
- Breastfeeding patients
- Unable (protected adults : tutorship, curatorship) orunwilling to consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Experimental group
Patients intaking full-dose OAC + ASA 100mg od
|
Patients will receive full-dose of OAC + Aspirin 100mg od during 24 to 48 months (until death or the end of the study : i.e. achievement of 2-year follow-up of the last included patient, maximum of 48-month followup for the first included patient)
|
Placebo Comparator: Control group
Patients intaking full-dose OAC + Placebo of ASA 100mg od
|
Patients will receive full-dose of OAC + placebo of Aspirin 100mg od during 24 to 48 months (until death or the end of the study : i.e. achievement of 2-year follow-up of the last included patient, maximum of 48-month followup for the first included patient)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary efficacy outcome : rate of composite of cardiovascular mortality and thrombotic cardiovascular events
Time Frame: within 24-48 months
|
The primary efficacy outcome is the incidence of the adjudicated composite of (within 24-48 months):
An Independent Clinical Events Committee (ICEC) will adjudicate all events (ischemic and bleeding events). |
within 24-48 months
|
Primary safety outcome : rate of major bleeding
Time Frame: within 24-48 months
|
The primary safety outcome is the occurrence of major bleeding according to the ISTH (International Society of Thrombosis and Haemostasis) definition
|
within 24-48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary efficacy outcomes : rate of composite of CV mortality, MI, stroke; CV mortality; all cause of death; thrombotic cardiovascular events.
Time Frame: within 24-48 months
|
The secondary efficacy outcomes are the occurrence of any of the following events:
|
within 24-48 months
|
Secondary safety outcomes : rate of major and clinically relevant non major bleeding
Time Frame: within 24-48 months
|
The secondary safety outcome are the occurrence of : Major and clinically relevant non major bleeding according to the ISTH definition (ISTH : International Society of Thrombosis and Haemostasis) Major bleeding (TIMI : Thrombolysis in Myocardial Infarction) Major bleeding (BARC ≥3 : Bleeding Academic Research Consensus) |
within 24-48 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Arrhythmias, Cardiac
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 29BRC19.0116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
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Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
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Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
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China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on OAC + Aspirin 100mg od
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedDrug-Induced Liver InjuryChina
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The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
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Azienda Ospedaliero Universitaria Maggiore della...Abbott Medical DevicesRecruitingLeft Atrial Appendage Occlusion | Antiplatelet TherapyItaly
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Royal Devon and Exeter NHS Foundation TrustUniversity of ExeterCompletedType 2 DiabetesUnited Kingdom
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St. Antonius HospitalCompletedMyocardial Infarction | Stroke | Bleeding | Aortic Valve DiseaseNetherlands, Belgium, Czechia, Luxembourg
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University College, LondonRecruitingCancer | Breast Cancer | Colorectal Cancer | Prostate Cancer | Gastro-oesophageal CancerIreland, United Kingdom
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Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
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Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
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Xijing HospitalActive, not recruitingAcute Coronary Syndrome | Angioplasty, Balloon | Antiplatelet DrugChina
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Beni-Suef UniversityRecruitingOral Pyogenic GranulomaEgypt