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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00501059
First received: July 12, 2007
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year CHD 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 Intervention Phase
Moderate Risk of CVD
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to first occurrence of the composite outcome of MI, stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack) [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA or TIA [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to incidence of all cause mortality [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of/ incidence of all cancers, excluding non melanoma skin cancer [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of/ incidence of colon cancer [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Incidence of MI, stroke, UA, TIA and CV death separately [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events (observed and reported), and changes in the physical examination findings, weight, and vital signs [ Time Frame: Approximately 56 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: Yes ]

Enrollment: 12551
Study Start Date: July 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
100mg enteric coated Aspirin, taken daily
Placebo Comparator: Arm 2 Drug: Placebo
Placebo, taken daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501059

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 39294
Graysville, Alabama, United States, 35073
Pell City, Alabama, United States, 35125
United States, Arizona
Phoenix, Arizona, United States, 85029
Phoenix, Arizona, United States, 85051
Phoenix, Arizona, United States, 85016
Scottsdale, Arizona, United States, 85260
Tucson, Arizona, United States, 85712
United States, Arkansas
Hot Springs, Arkansas, United States, 71913-4457
Little Rock, Arkansas, United States, 72202
United States, California
El Cajon, California, United States, 92019
Fremont, California, United States, 94536-3702
Garden Grove, California, United States, 92843
Glendora, California, United States, 91740
Huntington Beach, California, United States, 92647
Huntington Park, California, United States, 90255
Los Angeles, California, United States, 90025
Rancho Cucamonga, California, United States, 91730
Rolling Hills Estates, California, United States, 90274
San Diego, California, United States, 92114
San Francisco, California, United States, 94117
San Leandro, California, United States, 94578
Santa Ana, California, United States, 92704
Torrance, California, United States, 90503
Tulare, California, United States, 93274
United States, Delaware
Newark, Delaware, United States, 19702
United States, Florida
Altamonte Springs, Florida, United States, 32714
Boynton Beach, Florida, United States, 33426
Davie, Florida, United States, 33314
Gainesville, Florida, United States, 32601
Hallandale, Florida, United States, 33009
Hialeah, Florida, United States, 33016
Hollywood, Florida, United States, 33021
Kissimmee, Florida, United States, 34741
Lake Worth, Florida, United States, 33463
Largo, Florida, United States, 33770
Marianna, Florida, United States, 32446
Marianna, Florida, United States, 32446-2120
Merritt Island, Florida, United States, 32953
Miami, Florida, United States, 33155
Miami, Florida, United States, 33101
Panama City, Florida, United States, 32401
Plantation, Florida, United States, 33324
Port Richey, Florida, United States, 34668
Quincy, Florida, United States, 32351
Tampa, Florida, United States, 33624
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30318
Columbus, Georgia, United States, 31901
United States, Illinois
Chicago, Illinois, United States, 60628
Chicago, Illinois, United States, 60610
Chicago, Illinois, United States, 60631
Chicago, Illinois, United States, 60631-1958
Lockport, Illinois, United States, 60491
Morton, Illinois, United States, 61550
Peoria, Illinois, United States, 61406
Vernon Hills, Illinois, United States, 60061
United States, Indiana
Evansville, Indiana, United States, 47713
Fort Wayne, Indiana, United States, 46804
Kokomo, Indiana, United States, 46902
United States, Iowa
Des Moines, Iowa, United States, 50316
United States, Kentucky
Lebanon, Kentucky, United States, 40033
United States, Louisiana
Shreveport, Louisiana, United States, 71106
United States, Maine
Scarborough, Maine, United States, 04074
United States, Maryland
Annapolis, Maryland, United States, 21401
Baltimore, Maryland, United States, 21204
Baltimore, Maryland, United States, 21237
Elkton, Maryland, United States, 21921
Prince Frederick, Maryland, United States, 20678
United States, Massachusetts
Boston, Massachusetts, United States, 02120
Holden, Massachusetts, United States, 01520
United States, Michigan
Benzonia, Michigan, United States, 49616
Bridgman, Michigan, United States, 49106
Cadillac, Michigan, United States, 49601
Interlochen, Michigan, United States, 49643-9264
Sterling Heights, Michigan, United States, 48310
Troy, Michigan, United States, 48085
United States, Mississippi
Port Gibson, Mississippi, United States, 39150
Rolling Fork, Mississippi, United States, 39159
United States, Missouri
Florissant, Missouri, United States, 63031
United States, Nebraska
Broken Bow, Nebraska, United States, 68822
Omaha, Nebraska, United States, 68116-2004
Omaha, Nebraska, United States, 68114
United States, New Jersey
Belvidere, New Jersey, United States, 07823
Bridgewater, New Jersey, United States, 08807
Cherry Hill, New Jersey, United States, 08084
Clifton, New Jersey, United States, 07013
Elizabeth, New Jersey, United States, 07202
Flemington, New Jersey, United States, 08822
Glendora, New Jersey, United States, 08029
Hainesport, New Jersey, United States, 08036
Hillsborough, New Jersey, United States, 08844
Jersey City, New Jersey, United States, 07306
Lawrenceville, New Jersey, United States, 08648
Linden, New Jersey, United States, 07036
Monmouth Junction, New Jersey, United States, 08852
Perth Amboy, New Jersey, United States, 08861
Stratford, New Jersey, United States, 08084
Trenton, New Jersey, United States, 08618
Voorhees, New Jersey, United States, 08043
United States, New York
Brooklyn, New York, United States, 11229
Massapequa Park, New York, United States, 11762
New York, New York, United States, 10016
Rochester, New York, United States, 14626
Williamsville, New York, United States, 14221
United States, North Carolina
Burlington, North Carolina, United States, 27215
Columbus, North Carolina, United States, 28722
Graham, North Carolina, United States, 27253
Greensboro, North Carolina, United States, 27401
Raleigh, North Carolina, United States, 27609
United States, Ohio
Ashtabula, Ohio, United States, 44004
Carlisle, Ohio, United States, 45005-3320
Delaware, Ohio, United States, 43105
Marion, Ohio, United States, 43302
Montgomery, Ohio, United States, 45242
Perrysburg, Ohio, United States, 43551
Toledo, Ohio, United States, 43617
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Bend, Oregon, United States, 97701
United States, Pennsylvania
Bensalem, Pennsylvania, United States, 19020
Broomall, Pennsylvania, United States, 19008
Buckingham, Pennsylvania, United States, 18912
Dauphin, Pennsylvania, United States, 17018
Downingtown, Pennsylvania, United States, 19335
Doylestown, Pennsylvania, United States, 18901
Duncansville, Pennsylvania, United States, 16635
Erie, Pennsylvania, United States, 16504
Feasterville Trevose, Pennsylvania, United States, 19053
Philadelphia, Pennsylvania, United States, 19143
Phoenixville, Pennsylvania, United States, 19460
Sellersville, Pennsylvania, United States, 18960
Zionsville, Pennsylvania, United States, 18092
United States, Rhode Island
Warwick, Rhode Island, United States, 02888
United States, South Carolina
Greenville, South Carolina, United States, 29601
Simpsonville, South Carolina, United States, 29681
Taylors, South Carolina, United States, 29687
United States, Tennessee
Rogersville, Tennessee, United States, 37857
United States, Texas
Arlington, Texas, United States, 76012
Corpus Christi, Texas, United States, 78411
Daingerfield, Texas, United States, 75638
Dallas, Texas, United States, 75224
Houston, Texas, United States, 77088
Houston, Texas, United States, 77090
Humble, Texas, United States, 77338
Kingwood, Texas, United States, 77339
Lindale, Texas, United States, 75771
McKinney, Texas, United States, 75069
Rockwall, Texas, United States, 75032
San Antonio, Texas, United States, 78205-1116
San Marcos, Texas, United States, 78666
Spring, Texas, United States, 77379
Spring, Texas, United States, 77386
Stephenville, Texas, United States, 76401
Sugar Land, Texas, United States, 77478
Tomball, Texas, United States, 77375
United States, Utah
Salt Lake City, Utah, United States, 84124
Salt Lake City, Utah, United States, 84107
West Jordan, Utah, United States, 84088
United States, Virginia
Honaker, Virginia, United States, 24260
Richlands, Virginia, United States, 24641-2067
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53218
Germany
Allmendingen, Baden-Württemberg, Germany, 89604
Benningen, Baden-Württemberg, Germany, 71726
Deggingen, Baden-Württemberg, Germany, 73326
Dossenheim, Baden-Württemberg, Germany, 69221
Ettlingen, Baden-Württemberg, Germany, 78275
Freiburg, Baden-Württemberg, Germany, 79110
Graben-Neudorf, Baden-Württemberg, Germany, 76676
Gärtringen, Baden-Württemberg, Germany, 71116
Heidelberg, Baden-Württemberg, Germany, 69129
Heilbronn, Baden-Württemberg, Germany, 74080
Heilbronn, Baden-Württemberg, Germany, 74072
Hockenheim, Baden-Württemberg, Germany, 68766
Ludwigsburg, Baden-Württemberg, Germany, 71640
Schwetzingen, Baden-Württemberg, Germany, 68723
Sinzheim, Baden-Württemberg, Germany, 76547
Stockach, Baden-Württemberg, Germany, 78333
Stuttgart, Baden-Württemberg, Germany, 70378
Trossingen, Baden-Württemberg, Germany, 78647
Weinheim, Baden-Württemberg, Germany, 69469
Arzberg, Bayern, Germany, 95659
Bergrheinfeld, Bayern, Germany, 97493
Dinkelsbühl, Bayern, Germany, 91550
Gars, Bayern, Germany, 83536
Hohenau, Bayern, Germany, 94545
Künzing, Bayern, Germany, 94550
Landshut, Bayern, Germany, 84032
München, Bayern, Germany, 80336
Oberaurach, Bayern, Germany, 97514
Sand am Main, Bayern, Germany, 97522
Schrobenhausen, Bayern, Germany, 86529
Schwaig, Bayern, Germany, 90571
Spalt, Bayern, Germany, 91174
Strasskirchen, Bayern, Germany, 94342
Sulzbach-Rosenberg, Bayern, Germany, 92237
Ursensollen, Bayern, Germany, 92289
Cottbus, Brandenburg, Germany, 03046
Elsterwerda, Brandenburg, Germany, 04910
Gransee, Brandenburg, Germany, 16775
Ketzin, Brandenburg, Germany, 14669
Potsdam, Brandenburg, Germany, 14778
Frankfurt, Hessen, Germany, 60599
Frankfurt, Hessen, Germany, 60323
Frankfurt, Hessen, Germany, 65929
Frankfurt, Hessen, Germany, 60529
Hanau, Hessen, Germany, 63450
Kelkheim, Hessen, Germany, 65779
Oberursel, Hessen, Germany, 61440
Offenbach, Hessen, Germany, 63067
Offenbach, Hessen, Germany, 63073
Rodgau, Hessen, Germany, 63110
Rotenburg, Hessen, Germany, 36199
Wetter, Hessen, Germany, 35083
Laage, Mecklenburg-Vorpommern, Germany, 18299
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Aurich, Niedersachsen, Germany, 26603
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
Aachen, Nordrhein-Westfalen, Germany, 52080
Aachen, Nordrhein-Westfalen, Germany, 52074
Arnsberg, Nordrhein-Westfalen, Germany, 59757
Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
Bad Salzuflen, Nordrhein-Westfalen, Germany, 32108
Bad Salzuflen, Nordrhein-Westfalen, Germany, 32105
Bad Sassendorf, Nordrhein-Westfalen, Germany, 59505
Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51467
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, 40593
Düsseldorf, Nordrhein-Westfalen, Germany, 40477
Ense, Nordrhein-Westfalen, Germany, 59469
Essen, Nordrhein-Westfalen, Germany, 45355
Essen, Nordrhein-Westfalen, Germany, 45276
Essen, Nordrhein-Westfalen, Germany, 45136
Essen, Nordrhein-Westfalen, Germany, 45130
Essen, Nordrhein-Westfalen, Germany, 45359
Freudenberg, Nordrhein-Westfalen, Germany, 57258
Greven, Nordrhein-Westfalen, Germany, 48268
Grevenbroich, Nordrhein-Westfalen, Germany, 41515
Hamm, Nordrhein-Westfalen, Germany, 59069
Hünxe, Nordrhein-Westfalen, Germany, 46569
Kamp-Lintfort, Nordrhein-Westfalen, Germany, 47475
Krefeld, Nordrhein-Westfalen, Germany, 47798
Köln, Nordrhein-Westfalen, Germany, 51065
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, 41751
Viersen, Nordrhein-Westfalen, Germany, 41747
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, 67067
Ludwigshafen, Rheinland-Pfalz, Germany, 67069
Mainz, Rheinland-Pfalz, Germany, 55128
Mainz, Rheinland-Pfalz, Germany, 55127
Mainz, Rheinland-Pfalz, Germany, 55116
Nassau, Rheinland-Pfalz, Germany, 56377
Otterbach, Rheinland-Pfalz, Germany, 67731
Rhaunen, Rheinland-Pfalz, Germany, 55624
Speyer, Rheinland-Pfalz, Germany, 67346
Daaden, Saarland, Germany, 57567
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, 01219
Dresden, Sachsen, Germany, 01277
Dresden, Sachsen, Germany, 01069
Dresden, Sachsen, Germany, 01127
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
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
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, 12099
Berlin, Germany, 10249
Berlin, Germany, 13467
Berlin, Germany, 13057
Berlin, Germany, 14169
Berlin, Germany, 13055
Berlin, Germany, 10437
Berlin, Germany, 10407
Berlin, Germany, 14050
Berlin, Germany, 13405
Berlin, Germany, 10789
Hamburg, Germany, 22299
Hamburg, Germany, 22041
Hamburg, Germany, 22177
Hamburg, Germany, 22335
Hamburg, Germany, 22143
Rehburg-Loccum, Germany, 31547
Riede, Germany, 27339
Thedinghausen, Germany, 27321
Ireland
Bishopstown, Cork, Ireland
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
Italy
Amandola, Ascoli Piceno, Italy, 63021
Telese Terme, Benevento, Italy, 82037
Mariano Comense, Como, Italy, 22066
Chiavari, Genova, Italy, 16043
Legnano, Milano, Italy, 20025
Monza, Monza-Brianza, Italy, 20052
Scandiano, Reggio Emilia, Italy, 42019
Alassio, Savona, Italy, 17021
Laigueglia, Savona, Italy, 17053
Spotorno, Savona, Italy, 17028
Chieri, Torino, Italy, 10023
Moncalieri, Torino, Italy, 10024
Fagnano Olona, Varese, Italy, 21054
Alessandria, Italy, 15100
Arezzo, Italy, 52100
Asti, Italy, 14100
Bergamo, Italy, 24128
Catania, Italy, 95124
Chieti, Italy, 66100
Foggia, Italy, 71100
Genova, Italy, 16132
Gorizia, Italy, 34170
Grosseto, Italy, 58100
Milano, Italy, 20122
Napoli, Italy, 80131
Novara, Italy, 28100
Potenza, Italy, 85100
Reggio Calabria, Italy, 89100
Reggio Emilia, Italy, 42100
Roma, Italy, 00161
Roma, Italy, 00157
Roma, Italy, 00151
Roma, Italy, 00060
Savona, Italy, 17100
Torino, Italy, 10128
Varese, Italy, 21100
Poland
Bialystok, Poland, 15-183
Bydgoszcz, Poland
Bydgoszcz, Poland, 85-863
Chojnice, Poland, 89-604
Chrzanow, Poland
Czechowice-Dziedzice, Poland
Elblag, Poland, 82-300
Gdansk, Poland, 80-461
Gdansk, Poland, 80-822
Gdansk, Poland, 80-286
Gdynia, Poland, 81-317
Gliwice, Poland, 44-109
Gniewkowo, Poland, 88-140
Grodzisk Mazowiecki, Poland, 05-825
Inowroclaw, Poland
Katowice, Poland, 40-752
Katowice, Poland, 40-226
Krakow, Poland, 30-015
Krakow, Poland, 30-424
Krakow, Poland, 31-637
Krakow, Poland
Krakow, Poland, 31-567
Krakow, Poland, 31-011
Kutno, Poland, 99-300
Lancut, Poland
Linia, Poland, 84-223
Lodz, Poland
Lublin, Poland, 20-258
Lublin, Poland, 20-044
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
Tarnow, Poland, 33-100
Torun, Poland
Wabrzezno, Poland
Warszawa, Poland, 01-961
Warszawa, Poland, 01-192
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
Caguas, Puerto Rico, 00725
Guaynabo, Puerto Rico, 00968
Manati, Puerto Rico, 00674
Orocovis, Puerto Rico, 00720
San Juan, Puerto Rico, 00918
Trujilo Alto, Puerto Rico, 00976
Spain
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, 03503
Benidorm, Alicante, Spain, 03500
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, 03007
Alicante, Spain, 03005
Badajoz, Spain, 06140
Badajoz, Spain, 06011
Barcelona, Spain, 08025
Barcelona, Spain, 08023
Barcelona, Spain, 08017
Burgos, Spain, 09007
Huelva, Spain, 21003
León, Spain, 24005
León, Spain, 24001
León, Spain
León, Spain, 24009
Lugo, Spain, 27770
Madrid, Spain, 28030
Madrid, Spain, 28003
Madrid, Spain, 28032
Murcia, Spain, 300005
Murcia, Spain, 30003
Murcia, Spain, 30007
Murcia, Spain, 30008
Málaga, Spain, 29001
Salamanca, Spain, 37005
Salamanca, Spain, 27-31
Santander, Spain, 39009
Valencia, Spain, 46006
Valladolid, Spain, 47007
United Kingdom
Ballymena, Antrim, United Kingdom, BT43 6JD
Ballymena, Antrim, United Kingdom, BT42 4JP
Crumlin, Antrim, United Kingdom, BT29 4LP
Newtonabbey, Antrim, United Kingdom, BT37 9QU
Craigavon, Armagh, United Kingdom, BT67 0LQ
Bath, Avon, United Kingdom, BA11 2FH
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 5SQ
Ely, Cambridgeshire, United Kingdom, CB7 4HF
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, TR19 7HX
Penzance, Cornwall, United Kingdom, TR18 4EL
Penzance, Cornwall, United Kingdom, TR18 4JH
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 8SQ
Darlington, Durham, United Kingdom, DL3 7JR
Darlington, Durham, United Kingdom, DL3 6HZ
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
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
Coatrbridge, Lanarkshire, United Kingdom, ML5 3BJ
Forth, Lanarkshire, United Kingdom, ML1 8AJ
Blackpool, Lancashire, United Kingdom, FY4 3AD
Blackpool, Lancashire, United Kingdom, FY3 7EN
Bolton, Lancashire, United Kingdom, BL5 3UB
Bolton, Lancashire, United Kingdom, BL4 9QZ
Bolton, Lancashire, United Kingdom, BL3 6TL
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, BT41 3AE
Antrim, North Ireland, United Kingdom, BT37 9QN
Antrim, North Ireland, United Kingdom, BT36 4PP
Tyrone, North Ireland, United Kingdom, BT80 8BG
Wellingborough, Northamptonshire, United Kingdom, NN8 4RW
Chipping Norton, Oxfordshire, United Kingdom, OX7 5AL
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 St Edmonds, Suffolk, United Kingdom, IP30 9QU
Bury St. Edmunds, Suffolk, United Kingdom, IP32 7EW
Bury St. Edmunds, Suffolk, United Kingdom, IP31 2HD
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, CV7 8LA
Coventry, Warwickshire, United Kingdom, CV6 4DD
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, LS26 8SZ
Leeds, West Yorkshire, United Kingdom, LS25 7AB
Leeds, West Yorkshire, United Kingdom, LS25 1AN
Leeds, West Yorkshire, United Kingdom, LS15 9JH
Leeds, West Yorkshire, United Kingdom, LS10 3NB
Leeds, West Yorkshire, United Kingdom, LS25 1HB
Leeds, West Yorkshire, United Kingdom, LS9 9EF
Leeds, West Yorkshire, United Kingdom, LS118BS
Bradford-on-Avon, Wiltshire, United Kingdom, BA15 1DQ
Chippenham, Wiltshire, United Kingdom, SN15 2SB
Chippenham, Wiltshire, United Kingdom, SN14 6GT
Corsham, Wiltshire, United Kingdom, SN3 9DL
Corsham, Wiltshire, United Kingdom, SN13 8NA
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, BA2 4JT
Belfast, United Kingdom, BT15 2GE
Belfast, United Kingdom, BT8 7HR
Belfast, United Kingdom, BT12 5EY
Belfast, United Kingdom
Belfast, United Kingdom, BT5 7BP
Belfast, United Kingdom, BT1 2JR
Belfast, United Kingdom, BT13 3BW
Belfast, United Kingdom, BT12 5LT
Belfast, United Kingdom, BT14 7GB
Bellshill, United Kingdom, ML4 1PS
Blantyre, United Kingdom, G72 0BS
Cardiff, United Kingdom, CF5 4AD
Crossgar, United Kingdom, BT30 9JU
Doncaster, United Kingdom, DN1 2EU
Dundee, United Kingdom, DD19SY
Glasgow, United Kingdom, G52 3QN
Glasgow, United Kingdom, G67 1BJ
Glasgow, United Kingdom, G21 1TR
Glasgow, United Kingdom, G5 0BQ
Hamilton, United Kingdom, ML3 8AA
Hamilton, United Kingdom, ML3 7EN
Inverness, United Kingdom, IV2 4AG
Ipswich, United Kingdom, IP4 2PU
Ipswich, United Kingdom, IP2 0QQ
Liverpool, United Kingdom, L7 8XP
Lockerbie, United Kingdom, D11 2BJ
London, United Kingdom, SW12 8EU
London, United Kingdom, EC1M 6BQ
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 0EA
Wishaw, United Kingdom, ML2 7BQ
Witley Bay, United Kingdom, NE26 1NA
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00501059     History of Changes
Other Study ID Numbers: 12198, 2006-003622-29
Study First Received: July 12, 2007
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ethics Committee
Poland: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on October 19, 2014