A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (ARRIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501059
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Information provided by (Responsible Party):

Brief Summary:
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk. The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease (CVD) events, which include fatal and nonfatal myocardial infarction, fatal and nonfatal stroke and CV death, in a population with no history of known CVD who are at moderate risk of major CHD events (approximately 10-20% 10 year CHD risk). This corresponds to a patient population mean 10-year CVD risk of approximately 30%. Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician. Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board.

Condition or disease Intervention/treatment Phase
Moderate Risk of CVD Drug: Aspirin (Acetylsalicylic acid, BAYE4465) Drug: Placebo Phase 3

Detailed Description:

Summary of substantial Protocol amendments

Amendment #2 from 09-APR-2008:

  • Systolic blood pressure (SBP) limit of 170 mmHg has been added to the exclusion criteria
  • Exclusion of patients currently taking anticoagulant medication
  • A longer interval between the daily dose of study drug and ibuprofen
  • Revised wording in moderate risk definitions for coronary heart disease (CHD) and cerebrovascular disease (CVD): "To evaluate the clinical effects of a 100 mg/day enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events (approximately 10 to 20% 10-year CHD risk; approximately 20 to 30% 10-year risk of CVD). This corresponds to a patient population mean 10-year CVD risk of approximately 30%."

Amendment #3 from 02-JAN-2009

• Increase in the number of allowed risk factors for males, age is no longer a risk factor

Amendment #4 from 02-OCT-2013

  • The primary endpoint is changed to include confirmed UA and TIA.
  • The estimated event rate is changed to 1.5% per year due to new information.
  • Effect size (risk reduction) changed from 14.9% to 17 to 18%.
  • Achieving 60,000 person-years instead of 1488 primary endpoint events
  • Additional treatment and follow-up for a maximum of another 12 months.
  • Change to reduced adverse event and concomitant therapy reporting

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group Study to Assess the Efficacy (Reduction of Cardiovascular Disease Events) and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Actual Study Start Date : July 5, 2007
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : November 15, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Acetylsalicylic acid (Aspirin, BAYE4465)
Participants received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
100mg enteric coated Aspirin, taken daily

Placebo Comparator: Placebo
Participants received 1 tablets of matching placebo orally once daily.
Drug: Placebo
Placebo, taken daily

Primary Outcome Measures :
  1. Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) [ Time Frame: Until follow-up (approximate 6 years) ]
    The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

Secondary Outcome Measures :
  1. Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) [ Time Frame: Until follow-up (approximate 6 years) ]
    The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

  2. Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA [ Time Frame: Until follow-up (approximately 6 years) ]
    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

  3. Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer [ Time Frame: Until follow-up (approximately 6 years) ]
    The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.

  4. Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer [ Time Frame: Until follow-up (approximately 6 years) ]
  5. Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately [ Time Frame: Until follow-up (approximately 6 years) ]
    The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately.

Other Outcome Measures:
  1. Number of Subjects With Adjudicated GI Bleeding by Severity [ Time Frame: Until follow-up (approximate 6 years) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:

    • Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • Females aged 60 and above with 3 or more risk factors. Female Risk Factors:

    • Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Exclusion Criteria:

  • History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
  • Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
  • Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
  • Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
  • Active diagnosed and documented reflux esophagitis
  • Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
  • Lactating women or women of childbearing potential
  • Severe liver disease or damage based on the clinical judgment of the investigator
  • Severe renal disease or damage based on the clinical judgement of the investigator
  • A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
  • A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
  • Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
  • Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
  • Current use of an anticoagulant medication
  • Sitting systolic blood pressure greater than 170 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501059

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Elsterwerda, Brandenburg, Germany, 04910
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Ketzin, Brandenburg, Germany, 14669
Potsdam, Brandenburg, Germany, 14778
Frankfurt, Hessen, Germany, 60323
Frankfurt, Hessen, Germany, 60529
Frankfurt, Hessen, Germany, 60599
Frankfurt, Hessen, Germany, 65929
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Kelkheim, Hessen, Germany, 65779
Oberursel, Hessen, Germany, 61440
Offenbach, Hessen, Germany, 63067
Offenbach, Hessen, Germany, 63073
Rodgau, Hessen, Germany, 63110
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Wetter, Hessen, Germany, 35083
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Schwerin, Mecklenburg-Vorpommern, Germany, 19055
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Bockenem, Niedersachsen, Germany, 31167
Braunschweig, Niedersachsen, Germany, 38100
Horneburg, Niedersachsen, Germany, 21640
Jühnde, Niedersachsen, Germany, 37127
Loxstedt, Niedersachsen, Germany, 27612
Nienburg, Niedersachsen, Germany, 31582
Northeim, Niedersachsen, Germany, 37154
Papenburg, Niedersachsen, Germany, 26871
Stuhr, Niedersachsen, Germany, 28816
Wardenburg, Niedersachsen, Germany, 26203
Weyhe, Niedersachsen, Germany, 28844
Wilhelmshaven, Niedersachsen, Germany, 26384
Winsen, Niedersachsen, Germany, 21423
Worpswede, Niedersachsen, Germany, 27726
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Aachen, Nordrhein-Westfalen, Germany, 52080
Arnsberg, Nordrhein-Westfalen, Germany, 59757
Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
Bad Salzuflen, Nordrhein-Westfalen, Germany, 32105
Bad Salzuflen, Nordrhein-Westfalen, Germany, 32108
Bad Sassendorf, Nordrhein-Westfalen, Germany, 59505
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Bergkamen, Nordrhein-Westfalen, Germany, 59192
Bochum, Nordrhein-Westfalen, Germany, 44797
Dortmund, Nordrhein-Westfalen, Germany, 44139
Dortmund, Nordrhein-Westfalen, Germany, 44328
Dortmund, Nordrhein-Westfalen, Germany, 44339
Duisburg, Nordrhein-Westfalen, Germany, 47199
Düsseldorf, Nordrhein-Westfalen, Germany, 40477
Düsseldorf, Nordrhein-Westfalen, Germany, 40593
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Essen, Nordrhein-Westfalen, Germany, 45136
Essen, Nordrhein-Westfalen, Germany, 45276
Essen, Nordrhein-Westfalen, Germany, 45355
Essen, Nordrhein-Westfalen, Germany, 45359
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Köln, Nordrhein-Westfalen, Germany, 51069
Langenfeld, Nordrhein-Westfalen, Germany, 40764
Leverkusen, Nordrhein-Westfalen, Germany, 51373
Lienen, Nordrhein-Westfalen, Germany, 49536
Lippetal, Nordrhein-Westfalen, Germany, 59510
Löhne, Nordrhein-Westfalen, Germany, 32584
Marl, Nordrhein-Westfalen, Germany, 45770
Münster, Nordrhein-Westfalen, Germany, 48167
Netphen, Nordrhein-Westfalen, Germany, 57250
Neuss, Nordrhein-Westfalen, Germany, 41468
Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
Rees, Nordrhein-Westfalen, Germany, 46459
Remscheid, Nordrhein-Westfalen, Germany, 42897
Siegen, Nordrhein-Westfalen, Germany, 57072
Viersen, Nordrhein-Westfalen, Germany, 41747
Viersen, Nordrhein-Westfalen, Germany, 41751
Welver, Nordrhein-Westfalen, Germany, 59514
Wetter, Nordrhein-Westfalen, Germany, 58300
Witten, Nordrhein-Westfalen, Germany, 58455
Haßloch, Rheinland-Pfalz, Germany, 67454
Kallstadt, Rheinland-Pfalz, Germany, 67169
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Ludwigshafen, Rheinland-Pfalz, Germany, 67069
Mainz, Rheinland-Pfalz, Germany, 55116
Mainz, Rheinland-Pfalz, Germany, 55127
Mainz, Rheinland-Pfalz, Germany, 55128
Nassau, Rheinland-Pfalz, Germany, 56377
Otterbach, Rheinland-Pfalz, Germany, 67731
Rhaunen, Rheinland-Pfalz, Germany, 55624
Speyer, Rheinland-Pfalz, Germany, 67346
Bitterfeld, Sachsen-Anhalt, Germany, 06749
Halle, Sachsen-Anhalt, Germany, 06124
Magdeburg, Sachsen-Anhalt, Germany, 39104
Beucha, Sachsen, Germany, 04824
Borna, Sachsen, Germany, 04552
Delitzsch, Sachsen, Germany, 04509
Dresden, Sachsen, Germany, 01069
Dresden, Sachsen, Germany, 01127
Dresden, Sachsen, Germany, 01219
Dresden, Sachsen, Germany, 01277
Leipzig, Sachsen, Germany, 04103
Leipzig, Sachsen, Germany, 04177
Leipzig, Sachsen, Germany, 04249
Markkleeberg, Sachsen, Germany, 04416
Meißen, Sachsen, Germany, 01662
Oberwiesenthal, Sachsen, Germany, 09484
Riesa, Sachsen, Germany, 01587
Wermsdorf, Sachsen, Germany, 04779
Zwickau, Sachsen, Germany, 08056
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Lütjenburg, Schleswig-Holstein, Germany, 24321
Norderstedt, Schleswig-Holstein, Germany, 22844
Reinfeld, Schleswig-Holstein, Germany, 23858
Apolda, Thüringen, Germany, 99510
Blankenhain, Thüringen, Germany, 99444
Grimma, Thüringen, Germany, 04668
Weimar, Thüringen, Germany, 99423
Berlin, Germany, 10249
Berlin, Germany, 10407
Berlin, Germany, 10437
Berlin, Germany, 10789
Berlin, Germany, 12099
Berlin, Germany, 13055
Berlin, Germany, 13057
Berlin, Germany, 13405
Berlin, Germany, 13467
Berlin, Germany, 14050
Berlin, Germany, 14169
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Hamburg, Germany, 22041
Hamburg, Germany, 22143
Hamburg, Germany, 22177
Hamburg, Germany, 22299
Hamburg, Germany, 22335
Rehburg-Loccum, Germany, 31547
Riede, Germany, 27339
Thedinghausen, Germany, 27321
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Mallow, Cork, Ireland
Rathmines, Dublin, Ireland
Athenry, Galway, Ireland
Kinvara, Galway, Ireland
Killarney, Kerry, Ireland
Kilmallock, Limerick, Ireland
Rathkeale, Limerick, Ireland
Tallow, Waterford, Ireland
Tramore, Waterford, Ireland
Enniscorthy, Wexford, Ireland
Gorey, Wexford, Ireland
Bray, Wicklow, Ireland
Cork, Ireland
Dublin, Ireland, 2
Dublin, Ireland
Galway, Ireland
Limerick, Ireland
Waterford, Ireland
Chieti, Abruzzo, Italy, 66100
Amandola, Ascoli Piceno, Italy, 63021
Potenza, Basilicata, Italy, 85100
Benevento, Campania, Italy, 82037
Napoli, Campania, Italy, 80131
Reggio Emilia, Emilia-Romagna, Italy, 42019
Gorizia, Friuli-Venezia Giulia, Italy, 34170
Chiavari, Genova, Italy, 16043
Roma, Lazio, Italy, 00152
Roma, Lazio, Italy, 00157
Roma, Lazio, Italy, 00161
Genova, Liguria, Italy, 16132
Savona, Liguria, Italy, 17021
Savona, Liguria, Italy, 17100
Como, Lombardia, Italy, 22066
Milano, Lombardia, Italy, 20122
Monza-Brianza, Lombardia, Italy, 20052
Varese, Lombardia, Italy, 21054
Varese, Lombardia, Italy, 21100
Legnano, Milano, Italy, 20025
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10023
Foggia, Puglia, Italy, 71100
Alassio, Savona, Italy, 17021
Laigueglia, Savona, Italy, 17053
Spotorno, Savona, Italy, 17028
Catania, Sicilia, Italy, 95124
Chieri, Torino, Italy, 10023
Moncalieri, Torino, Italy, 10024
Arezzo, Toscana, Italy, 52100
Grosseto, Toscana, Italy, 58100
Alessandria, Italy, 15100
Asti, Italy, 14100
Bergamo, Italy, 24128
Reggio Calabria, Italy, 89100
Reggio Emilia, Italy, 42123
Roma, Italy, 00060
Torino, Italy, 10128
Bialystok, Poland, 15-183
Bydgoszcz, Poland, 85-863
Bydgoszcz, Poland
Chojnice, Poland, 89-604
Chrzanow, Poland
Czechowice-Dziedzice, Poland
Elblag, Poland, 82-300
Gdansk, Poland, 80-286
Gdansk, Poland, 80-461
Gdansk, Poland, 80-822
Gdynia, Poland, 81-317
Gliwice, Poland, 44-109
Gniewkowo, Poland, 88-140
Grodzisk Mazowiecki, Poland, 05-825
Inowroclaw, Poland
Katowice, Poland, 40-226
Katowice, Poland, 40-752
Krakow, Poland, 30-424
Krakow, Poland, 31-011
Krakow, Poland, 31-156
Krakow, Poland, 31-567
Krakow, Poland, 31-637
Krakow, Poland
Kutno, Poland, 99-300
Lancut, Poland
Linia, Poland, 84-223
Lodz, Poland
Lublin, Poland, 20-044
Lublin, Poland, 20-258
Lublin, Poland
Malaszewicze, Poland
Malbork, Poland, 82-200
Naklo nad Notecia, Poland, 98-100
Olkusz, Poland
Olsztyn, Poland
Ostrow Wielkopolski, Poland, 63-400
Porabka, Poland
Poznan, Poland, 60-539
Przeworsk, Poland, 37-200
Radom, Poland, 26-600
Rzeszow, Poland
Skierniewice, Poland, 96-100
Skierniewice, Poland
Sobotka, Poland
Sopot, Poland, 81-746
Szczyrk, Poland, 43-370
Tarnow, Poland, 33-100
Tarnow, Poland
Torun, Poland, 87-100
Wabrzezno, Poland
Warszawa, Poland, 01-192
Warszawa, Poland, 01-961
Warszawa, Poland, 02-507
Warszawa, Poland, 02-796
Wejherowo, Poland
Wloclawek, Poland
Wola, Poland
Wroclaw, Poland, 50-127
Wroclaw, Poland, 51-112
Wroclaw, Poland, 51-215
Wroclaw, Poland
Zabrze, Poland
Puerto Rico
Guaynabo, Puerto Rico, 00968
Manati, Puerto Rico, 00674
Orocovis, Puerto Rico, 00720
San Juan, Puerto Rico, 00918
Trujilo Alto, Puerto Rico, 00976
Sobrado Dos Monxes, A Coruña, Spain, 15813
Alatoz, Albacete, Spain, 02152
Chinchilla de Monte Aragón, Albacete, Spain, 02520
La Roda, Albacete, Spain, 06230
Benidorm, Alicante, Spain, 03500
Benidorm, Alicante, Spain, 03503
Elche, Alicante, Spain
Orihuela, Alicante, Spain, 03300
Petrer, Alicante, Spain, 03610
Xixona, Alicante, Spain, 03100
Huércal, Almería, Spain, 04230
Gijón, Asturias, Spain, 33212
Oviedo, Asturias, Spain, 33009
Oviedo, Asturias, Spain, 33012
Oviedo, Asturias, Spain, 33013
Posada De Llanes, Asturias, Spain, 33594
Centelles, Barcelona, Spain, 08540
Vic (Barcelona), Catalunya, Spain, 08500
Jérez de la Frontera, Cádiz, Spain, 11407
Begonte, Lugo, Spain, 27373
Viveiro, Lugo, Spain, 27850
Alcobendas, Madrid, Spain, 28100
Albarán, Murcia, Spain, 30550
Espinardo, Murcia, Spain, 30100
Zarandona, Murcia, Spain, 30007
Orense, Ourense, Spain, 32003
Gümar, Santa Cruz De Tenerife, Spain, 38591
La Victoria, Santa Cruz De Tenerife, Spain, 38380
Alcover, Tarragona, Spain, 43460
Beniganim, Valencia, Spain, 46830
Manises, Valencia, Spain, 46940
Albacete, Spain, 02005
Albacete, Spain, 2260
Alicante, Spain, 03005
Alicante, Spain, 03007
Badajoz, Spain, 06011
Badajoz, Spain, 06140
Barcelona, Spain, 08017
Barcelona, Spain, 08023
Barcelona, Spain, 08025
Burgos, Spain, 09007
Huelva, Spain, 21003
León, Spain, 24001
León, Spain, 24005
León, Spain, 24009
León, Spain
Lugo, Spain, 27770
Madrid, Spain, 28003
Madrid, Spain, 28030
Madrid, Spain, 28032
Murcia, Spain, 300005
Murcia, Spain, 30003
Murcia, Spain, 30007
Murcia, Spain, 30008
Málaga, Spain, 29001
Salamanca, Spain, 27-31
Salamanca, Spain, 37005
Santander, Spain, 39009
Valencia, Spain, 46006
Valladolid, Spain, 47007
United Kingdom
Ballymena, Antrim, United Kingdom, BT42 4JP
Ballymena, Antrim, United Kingdom, BT43 6JD
Crumlin, Antrim, United Kingdom, BT29 4LP
Newtonabbey, Antrim, United Kingdom, BT37 9QU
Craigavon, Armagh, United Kingdom, BT67 0LQ
Bath, Avon, United Kingdom, BA2 3HT
Bath, Avon, United Kingdom, BA2 4BY
Radstock, Avon, United Kingdom, BA3 2UH
Irvine, Ayrshire, United Kingdom, KA12 0AY
Luton, Bedfordshire, United Kingdom, LU2 9SB
Bracknell, Berkshire, United Kingdom, RG12 7WW
Slough, Berkshire, United Kingdom, SL1 1TT
Ely, Cambridgeshire, United Kingdom, CB7 4HF
Ely, Cambridgeshire, United Kingdom, CB7 5SQ
Peterborough, Cambridgeshire, United Kingdom, PE2 5GP
Peterborough, Cambridgeshire, United Kingdom, PE7 3JL
Sandbach, Cheshire, United Kingdom, CW11 1EQ
Boscastle, Cornwall, United Kingdom, PL35 0BG
Fowey, Cornwall, United Kingdom, PL23 1DT
Penzance, Cornwall, United Kingdom, TR18 4EL
Penzance, Cornwall, United Kingdom, TR18 4JH
Penzance, Cornwall, United Kingdom, TR19 7HX
Saltash, Cornwall, United Kingdom, PL12 6DL
St Austell, Cornwall, United Kingdom, PL26 7RL
Chesterfield, Derbyshire, United Kingdom, S40 4AA
Dronfield, Derbyshire, United Kingdom, S18 8QY
Plymouth, Devon, United Kingdom, PL6 7TH
Carryduff, Down, United Kingdom, BT8 8HR
Annan, Dumfries And Galloway, United Kingdom, DG12 6BG
Bishop Auckland, Durham, United Kingdom, DL14 6AB
Darlington, Durham, United Kingdom, DL2 1AA
Darlington, Durham, United Kingdom, DL3 6HZ
Darlington, Durham, United Kingdom, DL3 7JR
Darlington, Durham, United Kingdom, DL3 8SQ
Leigh-on-Sea, Essex, United Kingdom, SS9 2SQ
Tiptree, Essex, United Kingdom, CO5 0HB
High Valleyfield, Fife, United Kingdom, KY12 8SJ
Glasgow, Glasgow City, United Kingdom, G20 0XA
Bangor, Gwynedd, United Kingdom, BT19 1PP
Basingstoke, Hampshire, United Kingdom, RG25 3DZ
Hitchin, Hertfordshire, United Kingdom, SG4 9TH
Letchworth, Hertfordshire, United Kingdom, SG6 4TS
Letchworth, Hertfordshire, United Kingdom, SG6 4UB
Canterbury, Kent, United Kingdom, CT1 3HX
Chestfield, Kent, United Kingdom, CT5 3QU
Whitstable, Kent, United Kingdom, CT5 3SE
Carstairs, Lanarkshire, United Kingdom, ML11 8QD
Coatbridge, Lanarkshire, United Kingdom, ML5 3AP
Forth, Lanarkshire, United Kingdom, ML1 8AJ
Blackpool, Lancashire, United Kingdom, FY3 7EN
Blackpool, Lancashire, United Kingdom, FY4 3AD
Bolton, Lancashire, United Kingdom, BL3 6TL
Bolton, Lancashire, United Kingdom, BL4 9QZ
Bolton, Lancashire, United Kingdom, BL5 3UB
Hinckley, Leicestershire, United Kingdom, LE10 2SE
Ruislip, Middlesex, United Kingdom, HA4 7AE
Wells-Next-The-Sea, Norfolk, United Kingdom, NR23 1JP
Wymondham, Norfolk, United Kingdom, NR18 0RF
Antrim, North Ireland, United Kingdom, BT36 4PP
Antrim, North Ireland, United Kingdom, BT37 9QN
Antrim, North Ireland, United Kingdom, BT41 3AE
Tyrone, North Ireland, United Kingdom, BT80 8BG
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
Chipping Norton, Oxfordshire, United Kingdom, OX75FA
Eccles, Sheffield, United Kingdom, S35 9XQ
Bath, Somerset, United Kingdom, BA1 2SR
Barry, SOuth Glamorgan, United Kingdom, CF63 4HP
Doncaster, South Yorkshire, United Kingdom, DN1 2ET
Sheffield, South Yorkshire, United Kingdom, S7 2DW
Chapelhall, Stratchclyde, United Kingdom, ML6 8SR
Glasgow, Stratchclyde, United Kingdom, G45 9AW
Hamilton, Stratchclyde, United Kingdom, ML3 ODR
Johnstone, Stratchclyde, United Kingdom, PA5 8EY
Motherwell, Stratchclyde, United Kingdom, ML1 3JX
Bury Saint Edmonds, Suffolk, United Kingdom, IP30 9QU
Bury St. Edmunds, Suffolk, United Kingdom, IP31 2HD
Bury St. Edmunds, Suffolk, United Kingdom, IP32 7EW
Hadleigh, Suffolk, United Kingdom, IP7 5DN
Stowmarket, Suffolk, United Kingdom, IP14 1NL
Addlestone, Surrey, United Kingdom, KT15 2BH
East Horsley, Surrey, United Kingdom, KT24 6QT
Worcester Park, Surrey, United Kingdom, KT4 7BX
Dundee, Tayside, United Kingdom, DD1 5LA
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE15 6TQ
Coventry, Warwickshire, United Kingdom, CV6 4DD
Coventry, Warwickshire, United Kingdom, CV7 8LA
Rugby, Warwickshire, United Kingdom, CV21 3SP
Coventry, West Midlands, United Kingdom, CV9 1EU
Sutton Coldfield, West Midlands, United Kingdom, B74 3PL
West Bromwich, West Midlands, United Kingdom, B71 4HJ
Brighton, West Sussex, United Kingdom, BN2 1ES
Crawley, West Sussex, United Kingdom, RH10 1LL
Crawley, West Sussex, United Kingdom, RH10 7DX
Leeds, West Yorkshire, United Kingdom, LS10 3NB
Leeds, West Yorkshire, United Kingdom, LS118BS
Leeds, West Yorkshire, United Kingdom, LS15 9JH
Leeds, West Yorkshire, United Kingdom, LS25 1AN
Leeds, West Yorkshire, United Kingdom, LS25 1HB
Leeds, West Yorkshire, United Kingdom, LS25 7AB
Leeds, West Yorkshire, United Kingdom, LS26 8SZ
Leeds, West Yorkshire, United Kingdom, LS9 9EF
Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ
Chippenham, Wiltshire, United Kingdom, SN14 6GT
Chippenham, Wiltshire, United Kingdom, SN15 2SB
Corsham, Wiltshire, United Kingdom, SN13 8NA
Corsham, Wiltshire, United Kingdom, SN3 9DL
Trowbridge, Wiltshire, United Kingdom, BA14 9AR
Westbury, Wiltshire, United Kingdom, BA13 3FQ
Aberdeen, United Kingdom, AB25 2ZD
Airedire, United Kingdom, ML66DB
Antrim, United Kingdom, BT38 9TG
Bath, United Kingdom, BA11 2FH
Bath, United Kingdom, BA2 4JT
Belfast, United Kingdom, BT1 2JR
Belfast, United Kingdom, BT12 5EY
Belfast, United Kingdom, BT12 5LT
Belfast, United Kingdom, BT13 3BW
Belfast, United Kingdom, BT14 7GB
Belfast, United Kingdom, BT15 2GE
Belfast, United Kingdom, BT5 7BP
Belfast, United Kingdom, BT8 6GR
Belfast, United Kingdom
Bellshill, United Kingdom, ML4 1PS
Blantyre, United Kingdom, G72 0BS
Cardiff, United Kingdom, CF5 4AD
Coatrbridge, United Kingdom, ML5 3BJ
Crossgar, United Kingdom, BT30 9JU
Doncaster, United Kingdom, DN1 2EU
Dundee, United Kingdom, DD19SY
Glasgow, United Kingdom, G21 1TR
Glasgow, United Kingdom, G5 0BQ
Glasgow, United Kingdom, G52 3QN
Glasgow, United Kingdom, G67 1BJ
Hamilton, United Kingdom, ML3 7EN
Hamilton, United Kingdom, ML3 8AA
Inverness, United Kingdom, IV2 4AG
Ipswich, United Kingdom, IP2 0QQ
Ipswich, United Kingdom, IP4 2PU
Liverpool, United Kingdom, L7 8XP
Lockerbie, United Kingdom, D11 2BJ
London, United Kingdom, EC1M 6BQ
London, United Kingdom, SW12 8EU
Manchester, United Kingdom, M13 9WL
New Stevenson, United Kingdom, ML1 4LT
Paisley, United Kingdom
Peterborough, United Kingdom, PE8 6PL
Thornhill, United Kingdom, DG3 5AA
Watford, United Kingdom, WD25 7NL
Wishaw, United Kingdom, ML2 7BQ
Witley Bay, United Kingdom, NE26 1NA
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT00501059     History of Changes
Other Study ID Numbers: 12198
2006-003622-29 ( EudraCT Number )
First Posted: July 13, 2007    Key Record Dates
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Bayer:
Primary prevention of coronary heart disease
Stroke and cardiovascular death

Additional relevant MeSH terms:
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors