GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01671007
First received: August 20, 2012
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.
| Condition |
|---|
|
Stroke Atrial Fibrillation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States) |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- CHADS2 Score [cardiac failure, hypertension, age, diabetes, stroke (doubled)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- CHA2DS2VASc Score [cardiac failure, hypertension, age >=75 (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 and sex category (female)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- HAS-BLED score [hypertension, abnormal renal/liver function (1 point each), stroke, bleeding history or predisposition, labile international Normalized Ratio (INR), elderly (>65), drugs/alcohol concomitantly (1 point each)] [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Antithrombotic treatment choice at baseline [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Stroke (hemorrhagic and ischemic, uncertain classification) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- Transient ischemic attack (TIA) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- systemic embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- pulmonary embolism [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- myocardial infarction [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- life-threatening bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- Major bleeding events [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- All cause death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- Non-vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- Death of unknown cause [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
- composite endpoint: stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators outside the Summary of Product Characteristics (SmPC) indication. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators with contraindications (overall and per contraindication captured) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization of dabigatran initiators with relevant comedications that should be used with caution [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without assessment of renal function (no serum creatinine reported) prior treatment initiation. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 110 mg BID (twice daily) although 150 mg BID is recommended according to SmPC [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators receiving 150 mg BID although 110 mg BID is recommended according to SmPC (e.g. patients > 80 years or patients with high bleeding risk) [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
- Phase II only: Percentage and characterization (if feasible based on patient number) of dabigatran initiators without an interruption of dabigatran due to outcome events (e.g. major bleeds, major trauma), procedures. [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20540 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2020 |
| Estimated Primary Completion Date: | August 2020 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with non-valvular AF
Criteria
Inclusion criteria:
1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.
Exclusion criteria:
- Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
- Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
- AF with a generally reversible cause;
- Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671007
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Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Hide Study LocationsLocations
| Austria | |
| 1160.136.34007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bad Pirawarth, Austria | |
| 1160.136.34002 Boehringer Ingelheim Investigational Site | Recruiting |
| Innsbruck, Austria | |
| 1160.136.34001 Boehringer Ingelheim Investigational Site | Recruiting |
| Linz, Austria | |
| 1160.136.34009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Mödling, Austria | |
| 1160.136.34005 Boehringer Ingelheim Investigational Site | Recruiting |
| Neupölla, Austria | |
| 1160.136.34008 Boehringer Ingelheim Investigational Site | Recruiting |
| Oberwart, Austria | |
| 1160.136.34004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Wien, Austria | |
| 1160.136.34003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Wien, Austria | |
| 1160.136.34006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Wien, Austria | |
| 1160.136.34010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Wolfsberg, Austria | |
| Bulgaria | |
| 1160.136.36004 Boehringer Ingelheim Investigational Site | Recruiting |
| Burgas, Bulgaria | |
| 1160.136.36002 Boehringer Ingelheim Investigational Site | Recruiting |
| Kazanlak, Bulgaria | |
| 1160.136.36008 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Plovdiv, Bulgaria | |
| 1160.136.36005 Boehringer Ingelheim Investigational Site | Recruiting |
| Rousse, Bulgaria | |
| 1160.136.36001 Boehringer Ingelheim Investigational Site | Recruiting |
| Sevlievo, Bulgaria | |
| 1160.136.36013 Boehringer Ingelheim Investigational Site | Recruiting |
| Sliven, Bulgaria | |
| 1160.136.36007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Sofia, Bulgaria | |
| 1160.136.36012 Boehringer Ingelheim Investigational Site | Recruiting |
| Sofia, Bulgaria | |
| 1160.136.36003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Sofia, Bulgaria | |
| 1160.136.36010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Sofia, Bulgaria | |
| 1160.136.36011 Boehringer Ingelheim Investigational Site | Recruiting |
| Sofia, Bulgaria | |
| 1160.136.36014 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Sofia, Bulgaria | |
| 1160.136.36009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Stara Zagora, Bulgaria | |
| 1160.136.36015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Varna, Bulgaria | |
| 1160.136.36006 Boehringer Ingelheim Investigational Site | Recruiting |
| Yambol, Bulgaria | |
| Denmark | |
| 1160.136.18004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Aalborg, Denmark | |
| 1160.136.18005 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hillerød, Denmark | |
| 1160.136.18002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hvidovre, Denmark | |
| 1160.136.18001 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Odense, Denmark | |
| El Salvador | |
| 1160.136.03021 Boehringer Ingelheim Investigational Site | Recruiting |
| Valencia, El Salvador | |
| Estonia | |
| 1160.136.38001 Boehringer Ingelheim Investigational Site | Recruiting |
| Tallin, Estonia | |
| 1160.136.38002 Boehringer Ingelheim Investigational Site | Recruiting |
| Tallinn, Estonia | |
| France | |
| 1160.136.13016 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Amiens, France | |
| 1160.136.13059 Boehringer Ingelheim Investigational Site | Recruiting |
| Arbois, France | |
| 1160.136.13060 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Avignon, France | |
| 1160.136.13035 Boehringer Ingelheim Investigational Site | Recruiting |
| Bagnols sur Ceze, France | |
| 1160.136.13015 Boehringer Ingelheim Investigational Site | Recruiting |
| Bersée, France | |
| 1160.136.13039 Boehringer Ingelheim Investigational Site | Recruiting |
| Besancon, France | |
| 1160.136.13036 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Beziers, France | |
| 1160.136.13040 Boehringer Ingelheim Investigational Site | Recruiting |
| Beziers, France | |
| 1160.136.13004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bordeaux, France | |
| 1160.136.13087 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Brive La Gaillarde, France | |
| 1160.136.13076 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Brive La Gaillarde, France | |
| 1160.136.13045 Boehringer Ingelheim Investigational Site | Recruiting |
| Broglie, France | |
| 1160.136.13054 Boehringer Ingelheim Investigational Site | Recruiting |
| Bruay la Buissière, France | |
| 1160.136.13037 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Béziers, France | |
| 1160.136.13031 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Caen, France | |
| 1160.136.13014 Boehringer Ingelheim Investigational Site | Recruiting |
| Cannes, France | |
| 1160.136.13046 Boehringer Ingelheim Investigational Site | Recruiting |
| Chateauroux, France | |
| 1160.136.13061 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Chateauroux, France | |
| 1160.136.13025 Boehringer Ingelheim Investigational Site | Recruiting |
| Cherbourg, France | |
| 1160.136.13062 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Cholet, France | |
| 1160.136.13055 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Clermont Ferrand, France | |
| 1160.136.13017 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Clermont Ferrand, France | |
| 1160.136.13057 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Corbeil-Essonnes, France | |
| 1160.136.13027 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Créteil, France | |
| 1160.136.13073 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Dijon, France | |
| 1160.136.13074 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Dole, France | |
| 1160.136.13077 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Epernay, France | |
| 1160.136.13063 Boehringer Ingelheim Investigational Site | Recruiting |
| Evecquemont, France | |
| 1160.136.13012 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Evreux, France | |
| 1160.136.13051 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Firminy, France | |
| 1160.136.13022 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Foix, France | |
| 1160.136.13005 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| La Teste de Buch, France | |
| 1160.136.13006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| La Tronche, France | |
| 1160.136.13084 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Le Chesnay, France | |
| 1160.136.13058 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Le Coudray, France | |
| 1160.136.13032 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Le Mans, France | |
| 1160.136.13029 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Le Perreux sur Marne, France | |
| 1160.136.13090 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Lens, France | |
| 1160.136.13010 Boehringer Ingelheim Investigational Site | Recruiting |
| Levallois Perret, France | |
| 1160.136.13008 Boehringer Ingelheim Investigational Site | Recruiting |
| Libourne, France | |
| 1160.136.13044 Boehringer Ingelheim Investigational Site | Recruiting |
| Libourne, France | |
| 1160.136.13079 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Limoges, France | |
| 1160.136.13078 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Limoges, France | |
| 1160.136.13052 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Maisons Alfort, France | |
| 1160.136.13024 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Marseille, France | |
| 1160.136.13080 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Marseille, France | |
| 1160.136.13075 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Marseille, France | |
| 1160.136.13047 Boehringer Ingelheim Investigational Site | Recruiting |
| Marseille cedex 5, France | |
| 1160.136.13081 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Metz-Tessy, France | |
| 1160.136.13019 Boehringer Ingelheim Investigational Site | Recruiting |
| Mondelange, France | |
| 1160.136.13056 Boehringer Ingelheim Investigational Site | Recruiting |
| Montargis, France | |
| 1160.136.13013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montauban, France | |
| 1160.136.13053 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montauban, France | |
| 1160.136.13033 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montbeliard, France | |
| 1160.136.13048 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montfermeil, France | |
| 1160.136.13001 Boehringer Ingelheim Investigational Site | Recruiting |
| Montfermeil, France | |
| 1160.136.13072 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montpellier, France | |
| 1160.136.13041 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Nantes, France | |
| 1160.136.13064 Boehringer Ingelheim Investigational Site | Recruiting |
| Neuilly sur Seine, France | |
| 1160.136.13018 Boehringer Ingelheim Investigational Site | Recruiting |
| Nimes, France | |
| 1160.136.13085 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Nîmes, France | |
| 1160.136.13049 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Nïmes, France | |
| 1160.136.13065 Boehringer Ingelheim Investigational Site | Recruiting |
| Orléans, France | |
| 1160.136.13007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Paris, France | |
| 1160.136.13071 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Paris, France | |
| 1160.136.13002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Pessac, France | |
| 1160.136.13011 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rambouillet, France | |
| 1160.136.13066 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rennes Cedex, France | |
| 1160.136.13086 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rennes Cedex, France | |
| 1160.136.13088 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rodez, France | |
| 1160.136.13042 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rosiers d'Egletons, France | |
| 1160.136.13034 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Saint Georges de Didone, France | |
| 1160.136.13089 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Saint-Jean, France | |
| 1160.136.13026 Boehringer Ingelheim Investigational Site | Recruiting |
| Saint-Yrieix-la-Perche, France | |
| 1160.136.13030 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Strasbourg, France | |
| 1160.136.13067 Boehringer Ingelheim Investigational Site | Recruiting |
| Strasbourg, France | |
| 1160.136.13082 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Thionville, France | |
| 1160.136.13068 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Toulon, France | |
| 1160.136.13020 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Toulouse, France | |
| 1160.136.13083 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Toulouse, France | |
| 1160.136.13023 Boehringer Ingelheim Investigational Site | Recruiting |
| Toulouse, France | |
| 1160.136.13003 Boehringer Ingelheim Investigational Site | Recruiting |
| Tourcoing, France | |
| 1160.136.13043 Boehringer Ingelheim Investigational Site | Recruiting |
| Tours, France | |
| 1160.136.13050 Boehringer Ingelheim Investigational Site | Recruiting |
| Valence, France | |
| 1160.136.13069 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vannes, France | |
| 1160.136.13028 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vendôme, France | |
| 1160.136.13070 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vichy, France | |
| 1160.136.13021 Boehringer Ingelheim Investigational Site | Recruiting |
| Vihiers, France | |
| 1160.136.13038 Boehringer Ingelheim Investigational Site | Recruiting |
| Wattrelos, France | |
| Germany | |
| 1160.136.02043 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Berlin, Germany | |
| 1160.136.02001 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02016 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02021 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02036 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02020 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02039 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1160.136.02040 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bochum, Germany | |
| 1160.136.02042 Boehringer Ingelheim Investigational Site | Recruiting |
| Bremen, Germany | |
| 1160.136.02017 Boehringer Ingelheim Investigational Site | Recruiting |
| Dessau-Roßlau, Germany | |
| 1160.136.02041 Boehringer Ingelheim Investigational Site | Recruiting |
| Detmold, Germany | |
| 1160.136.02014 Boehringer Ingelheim Investigational Site | Recruiting |
| Dinslaken, Germany | |
| 1160.136.02033 Boehringer Ingelheim Investigational Site | Recruiting |
| Dortmund, Germany | |
| 1160.136.02024 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Dresden, Germany | |
| 1160.136.02034 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Dresden, Germany | |
| 1160.136.02044 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Erlangen, Germany | |
| 1160.136.02032 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Essen, Germany | |
| 1160.136.02025 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Esslingen, Germany | |
| 1160.136.02015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Halle, Germany | |
| 1160.136.02046 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hamburg, Germany | |
| 1160.136.02048 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hamburg, Germany | |
| 1160.136.02052 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Hamburg, Germany | |
| 1160.136.02051 Boehringer Ingelheim Investigational Site | Recruiting |
| Ingolstadt, Germany | |
| 1160.136.02006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Itzehoe, Germany | |
| 1160.136.02022 Boehringer Ingelheim Investigational Site | Recruiting |
| Kassel, Germany | |
| 1160.136.02013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Kassel, Germany | |
| 1160.136.02009 Boehringer Ingelheim Investigational Site | Recruiting |
| Kempen, Germany | |
| 1160.136.02030 Boehringer Ingelheim Investigational Site | Recruiting |
| Kirchzarten, Germany | |
| 1160.136.02027 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Leipzig, Germany | |
| 1160.136.02026 Boehringer Ingelheim Investigational Site | Recruiting |
| Leverkusen, Germany | |
| 1160.136.02028 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Lippstadt, Germany | |
| 1160.136.02008 Boehringer Ingelheim Investigational Site | Recruiting |
| Ludwigsburg, Germany | |
| 1160.136.02018 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Lünen, Germany | |
| 1160.136.02023 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Magdeburg, Germany | |
| 1160.136.02053 Boehringer Ingelheim Investigational Site | Recruiting |
| Mainz, Germany | |
| 1160.136.02012 Boehringer Ingelheim Investigational Site | Recruiting |
| Markkleeberg, Germany | |
| 1160.136.02007 Boehringer Ingelheim Investigational Site | Recruiting |
| Mühldorf, Germany | |
| 1160.136.02010 Boehringer Ingelheim Investigational Site | Recruiting |
| München, Germany | |
| 1160.136.02002 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Northeim, Germany | |
| 1160.136.02004 Boehringer Ingelheim Investigational Site | Recruiting |
| Nürnberg, Germany | |
| 1160.136.02045 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Peine, Germany | |
| 1160.136.02031 Boehringer Ingelheim Investigational Site | Recruiting |
| Potsdam, Germany | |
| 1160.136.02035 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Rostock, Germany | |
| 1160.136.02005 Boehringer Ingelheim Investigational Site | Recruiting |
| Ulm, Germany | |
| 1160.136.02037 Boehringer Ingelheim Investigational Site | Recruiting |
| Villingen-Schwenningen, Germany | |
| 1160.136.02029 Boehringer Ingelheim Investigational Site | Recruiting |
| Vöhringen, Germany | |
| 1160.136.02049 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Warendorf, Germany | |
| 1160.136.02011 Boehringer Ingelheim Investigational Site | Recruiting |
| Wittenberg, Germany | |
| 1160.136.02047 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Würzburg, Germany | |
| Latvia | |
| 1160.136.37002 Boehringer Ingelheim Investigational Site | Recruiting |
| Liepaja, Latvia | |
| 1160.136.37001 Boehringer Ingelheim Investigational Site | Recruiting |
| Riga, Latvia | |
| 1160.136.37003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Riga, Latvia | |
| Netherlands | |
| 1160.136.01004 Boehringer Ingelheim Investigational Site | Recruiting |
| 's HERTOGENBOSCH, Netherlands | |
| 1160.136.01011 Boehringer Ingelheim Investigational Site | Recruiting |
| Amsterdam, Netherlands | |
| 1160.136.01007 Boehringer Ingelheim Investigational Site | Recruiting |
| Delft, Netherlands | |
| 1160.136.01002 Boehringer Ingelheim Investigational Site | Recruiting |
| Deventer, Netherlands | |
| 1160.136.01008 Boehringer Ingelheim Investigational Site | Recruiting |
| Dirksland, Netherlands | |
| 1160.136.01001 Boehringer Ingelheim Investigational Site | Recruiting |
| Enschede, Netherlands | |
| 1160.136.01012 Boehringer Ingelheim Investigational Site | Recruiting |
| Geleen, Netherlands | |
| 1160.136.01009 Boehringer Ingelheim Investigational Site | Recruiting |
| Heerlen, Netherlands | |
| 1160.136.01006 Boehringer Ingelheim Investigational Site | Recruiting |
| Hoogeveen, Netherlands | |
| 1160.136.01003 Boehringer Ingelheim Investigational Site | Recruiting |
| Maastricht, Netherlands | |
| 1160.136.01010 Boehringer Ingelheim Investigational Site | Recruiting |
| Sneek, Netherlands | |
| 1160.136.01013 Boehringer Ingelheim Investigational Site | Recruiting |
| Tiel, Netherlands | |
| 1160.136.01005 Boehringer Ingelheim Investigational Site | Recruiting |
| Venray, Netherlands | |
| Norway | |
| 1160.136.16002 Boehringer Ingelheim Investigational Site | Recruiting |
| Arendal, Norway | |
| 1160.136.16001 Boehringer Ingelheim Investigational Site | Recruiting |
| Fornebu, Norway | |
| 1160.136.16004 Boehringer Ingelheim Investigational Site | Recruiting |
| Kongsvinger, Norway | |
| 1160.136.16005 Boehringer Ingelheim Investigational Site | Recruiting |
| Lillehammer, Norway | |
| 1160.136.16003 Boehringer Ingelheim Investigational Site | Recruiting |
| RUD, Norway | |
| 1160.136.16006 Boehringer Ingelheim Investigational Site | Recruiting |
| Tromsø, Norway | |
| Portugal | |
| 1160.136.17014 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Alcabideche, Portugal | |
| 1160.136.17005 Boehringer Ingelheim Investigational Site | Recruiting |
| Almada, Portugal | |
| 1160.136.17001 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Carnaxide, Portugal | |
| 1160.136.17006 Boehringer Ingelheim Investigational Site | Recruiting |
| Covilhã, Portugal | |
| 1160.136.17016 Boehringer Ingelheim Investigational Site | Recruiting |
| Faro, Portugal | |
| 1160.136.17003 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Lisboa, Portugal | |
| 1160.136.17002 Boehringer Ingelheim Investigational Site | Recruiting |
| Lisboa, Portugal | |
| 1160.136.17010 Boehringer Ingelheim Investigational Site | Recruiting |
| Lisboa, Portugal | |
| 1160.136.17004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Lisboa, Portugal | |
| 1160.136.17018 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Matosinhos, Portugal | |
| 1160.136.17017 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Penafiel, Portugal | |
| 1160.136.17009 Boehringer Ingelheim Investigational Site | Recruiting |
| Porto, Portugal | |
| 1160.136.17012 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Santa Maria da Feira, Portugal | |
| 1160.136.17011 Boehringer Ingelheim Investigational Site | Recruiting |
| Setúbal, Portugal | |
| 1160.136.17019 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Setúbal, Portugal | |
| 1160.136.17015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vila Nova de Gaia, Portugal | |
| 1160.136.17020 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Vila Real, Portugal | |
| 1160.136.17013 Boehringer Ingelheim Investigational Site | Recruiting |
| Évora, Portugal | |
| Romania | |
| 1160.136.40013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Braila, Romania | |
| 1160.136.40014 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bucharest, Romania | |
| 1160.136.40009 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bucharest, Romania | |
| 1160.136.40012 Boehringer Ingelheim Investigational Site | Recruiting |
| Bucharest, Romania | |
| 1160.136.40015 Boehringer Ingelheim Investigational Site | Recruiting |
| Bucharest, Romania | |
| 1160.136.40010 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Bucharest, Romania | |
| 1160.136.40006 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Cluj Napoca, Romania | |
| 1160.136.40003 Boehringer Ingelheim Investigational Site | Recruiting |
| Cluj Napoca, Romania | |
| 1160.136.40002 Boehringer Ingelheim Investigational Site | Recruiting |
| Constanta, Romania | |
| 1160.136.40001 Boehringer Ingelheim Investigational Site | Recruiting |
| Craiova, Romania | |
| 1160.136.40008 Boehringer Ingelheim Investigational Site | Recruiting |
| Iasi, Romania | |
| 1160.136.40011 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Iasi, Romania | |
| 1160.136.40007 Boehringer Ingelheim Investigational Site | Recruiting |
| Oradea, Romania | |
| 1160.136.40005 Boehringer Ingelheim Investigational Site | Recruiting |
| Targu Mures, Romania | |
| 1160.136.40004 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Timisoara, Romania | |
| Slovenia | |
| 1160.136.42001 Boehringer Ingelheim Investigational Site | Recruiting |
| Celje, Slovenia | |
| 1160.136.42002 Boehringer Ingelheim Investigational Site | Recruiting |
| Ljubljana, Slovenia | |
| Spain | |
| 1160.136.03046 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Barcelona, Spain | |
| 1160.136.03009 Boehringer Ingelheim Investigational Site | Recruiting |
| Barcelona, Spain | |
| 1160.136.03042 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Barcelona, Spain | |
| 1160.136.03013 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Barcelona, Spain | |
| 1160.136.03094 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Barcelona, Spain | |
| 1160.136.03022 Boehringer Ingelheim Investigational Site | Recruiting |
| Bilbao, Spain | |
| 1160.136.03027 Boehringer Ingelheim Investigational Site | Recruiting |
| Casar de Caceres, Spain | |
| 1160.136.03017 Boehringer Ingelheim Investigational Site | Recruiting |
| Donostia-San Sebastian, Spain | |
| 1160.136.03005 Boehringer Ingelheim Investigational Site | Recruiting |
| El Palmar - Murcia, Spain | |
| 1160.136.03031 Boehringer Ingelheim Investigational Site | Recruiting |
| Granada, Spain | |
| 1160.136.03035 Boehringer Ingelheim Investigational Site | Recruiting |
| Jerez de la Frontera - Cádiz, Spain | |
| 1160.136.03020 Boehringer Ingelheim Investigational Site | Recruiting |
| Las Palmas de Gran Canaria, Spain | |
| 1160.136.03043 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Leganes - Madrid, Spain | |
| 1160.136.03039 Boehringer Ingelheim Investigational Site | Recruiting |
| León, Spain | |
| 1160.136.03018 Boehringer Ingelheim Investigational Site | Recruiting |
| Lugo, Spain | |
| 1160.136.03026 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03033 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03028 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03002 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03016 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03011 Boehringer Ingelheim Investigational Site | Recruiting |
| Madrid, Spain | |
| 1160.136.03003 Boehringer Ingelheim Investigational Site | Recruiting |
| Malaga, Spain | |
| 1160.136.03024 Boehringer Ingelheim Investigational Site | Recruiting |
| Marbella . Málaga, Spain | |
| 1160.136.03025 Boehringer Ingelheim Investigational Site | Recruiting |
| Málaga - Marbella, Spain | |
| 1160.136.03036 Boehringer Ingelheim Investigational Site | Recruiting |
| Palma de Mallorca, Spain | |
| 1160.136.03045 Boehringer Ingelheim Investigational Site | Recruiting |
| Pamplona, Spain | |
| 1160.136.03030 Boehringer Ingelheim Investigational Site | Recruiting |
| San Juan de Alicante, Spain | |
| 1160.136.03040 Boehringer Ingelheim Investigational Site | Recruiting |
| Sant Joan Despi, Spain | |
| 1160.136.03041 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Santander, Spain | |
| 1160.136.03012 Boehringer Ingelheim Investigational Site | Recruiting |
| Santiago de Compostela, Spain | |
| 1160.136.03019 Boehringer Ingelheim Investigational Site | Recruiting |
| Santiago de Compostela, Spain | |
| 1160.136.03001 Boehringer Ingelheim Investigational Site | Recruiting |
| Sevilla, Spain | |
| 1160.136.03034 Boehringer Ingelheim Investigational Site | Recruiting |
| Valencia, Spain | |
| 1160.136.03038 Boehringer Ingelheim Investigational Site | Recruiting |
| Valencia, Spain | |
| 1160.136.03010 Boehringer Ingelheim Investigational Site | Recruiting |
| Valencia, Spain | |
| 1160.136.03032 Boehringer Ingelheim Investigational Site | Recruiting |
| Vigo, Spain | |
| 1160.136.03037 Boehringer Ingelheim Investigational Site | Recruiting |
| Vigo, Spain | |
| Sweden | |
| 1160.136.19006 Boehringer Ingelheim Investigational Site | Recruiting |
| Falun, Sweden | |
| 1160.136.19011 Boehringer Ingelheim Investigational Site | Recruiting |
| Göteborg, Sweden | |
| 1160.136.19008 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Linköping, Sweden | |
| 1160.136.19001 Boehringer Ingelheim Investigational Site | Recruiting |
| Malmö, Sweden | |
| 1160.136.19002 Boehringer Ingelheim Investigational Site | Recruiting |
| Stockholm, Sweden | |
| 1160.136.19015 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Stockholm, Sweden | |
| 1160.136.19009 Boehringer Ingelheim Investigational Site | Recruiting |
| Umeå, Sweden | |
| 1160.136.19014 Boehringer Ingelheim Investigational Site | Recruiting |
| Västerås, Sweden | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01671007 History of Changes |
| Other Study ID Numbers: | 1160.136 |
| Study First Received: | August 20, 2012 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Austria: Medicines and Medical Devices Agency Bulgaria: Bulgarian Drug Agency Croatia: Agency for Medicinal Product and Medical Devices Czech Republic: State Institute for Drug Control Denmark: Danish Dataprotection Agency Estonia: The State Agency of Medicine France: French Data Protection Authority Germany: Ethics Commission Greece: Ethics Committee Ireland: Irish Medicines Board Italy: Ethics Committee Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medical Ethics Review Committee (METC) Norway:National Committee for Medical and Health Research Ethics Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Spanish Agency of Medicines Sweden: United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Atrial Fibrillation Stroke Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013