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

NCT ID: NCT00501059

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12546 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-05
• Study Completion Date: 2016-11-15

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.

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

Conditions

Moderate Risk of CVD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Acetylsalicylic acid (Aspirin, BAYE4465)

Participants received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.

Group Type: EXPERIMENTAL

Aspirin (Acetylsalicylic acid, BAYE4465)

Intervention Type: DRUG

100mg enteric coated Aspirin, taken daily

Placebo

Participants received 1 tablets of matching placebo orally once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, taken daily

Interventions

Aspirin (Acetylsalicylic acid, BAYE4465)

100mg enteric coated Aspirin, taken daily

Intervention Type: DRUG

Placebo

Placebo, taken daily

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Birmingham, Alabama, United States

Graysville, Alabama, United States

Pell City, Alabama, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Hot Springs, Arkansas, United States

Fremont, California, United States

Huntington Park, California, United States

Los Angeles, California, United States

Rancho Cucamonga, California, United States

Rolling Hills Estates, California, United States

Helping Hands Clinical Trials

Santa Ana, California, United States

Newark, Delaware, United States

Medical Research Trust

Boynton Beach, Florida, United States

Gainesville, Florida, United States

Hialeah, Florida, United States

Medical Research Centers of South Florida, Inc.

Hollywood, Florida, United States

Office of Dr.Larry Levinson, DO

Hollywood, Florida, United States

Kissimmee, Florida, United States

Largo, Florida, United States

Marianna, Florida, United States

Panama City, Florida, United States

Tallahassee Memorial Family

Quincy, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Lockport, Illinois, United States

Vernon Hills, Illinois, United States

Evansville, Indiana, United States

Fort Wayne, Indiana, United States

Lebanon, Kentucky, United States

Prince Frederick, Maryland, United States

Bridgman, Michigan, United States

Cadillac, Michigan, United States

Interlochen, Michigan, United States

Troy, Michigan, United States

Port Gibson, Mississippi, United States

Florissant, Missouri, United States

Broken Bow, Nebraska, United States

Omaha, Nebraska, United States

Omaha, Nebraska, United States

Belvidere, New Jersey, United States

Cherry Hill, New Jersey, United States

Clifton, New Jersey, United States

Hainesport, New Jersey, United States

Jersey City, New Jersey, United States

Lawrenceville, New Jersey, United States

Linden, New Jersey, United States

PharmaTrials, Inc.

Perth Amboy, New Jersey, United States

Stratford, New Jersey, United States

Burlington, North Carolina, United States

Columbus, North Carolina, United States

Greensboro, North Carolina, United States

Raleigh, North Carolina, United States

Carlisle, Ohio, United States

Marion, Ohio, United States

Montgomery, Ohio, United States

Perrysburg, Ohio, United States

Doylestown, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Taylors, South Carolina, United States

Daingerfield, Texas, United States

McKinney, Texas, United States

Rockwall, Texas, United States

San Antonio, Texas, United States

San Marcos, Texas, United States

Stephenville, Texas, United States

Sugar Land, Texas, United States

Honaker, Virginia, United States

Merit Medical Group, Inc.

Richlands, Virginia, United States

Benningen am Neckar, Baden-Wurttemberg, Germany

Deggingen, Baden-Wurttemberg, Germany

Dossenheim, Baden-Wurttemberg, Germany

Ettlingen, Baden-Wurttemberg, Germany

Graben-Neudorf, Baden-Wurttemberg, Germany

Heilbronn, Baden-Wurttemberg, Germany

Hockenheim, Baden-Wurttemberg, Germany

Ludwigsburg, Baden-Wurttemberg, Germany

Schwetzingen, Baden-Wurttemberg, Germany

Sinzheim, Baden-Wurttemberg, Germany

Stockach, Baden-Wurttemberg, Germany

Stuttgart, Baden-Wurttemberg, Germany

Trossingen, Baden-Wurttemberg, Germany

Weinheim, Baden-Wurttemberg, Germany

Arzberg, Bavaria, Germany

Bergrheinfeld, Bavaria, Germany

Dinkelsbühl, Bavaria, Germany

Gars, Bavaria, Germany

Hohenau, Bavaria, Germany

Künzing, Bavaria, Germany

München, Bavaria, Germany

Oberaurach, Bavaria, Germany

Sand Am Main, Bavaria, Germany

Schrobenhausen, Bavaria, Germany

Spalt, Bavaria, Germany

Straßkirchen, Bavaria, Germany

Sulzbach-Rosenberg, Bavaria, Germany

Ursensollen, Bavaria, Germany

Cottbus, Brandenburg, Germany

Elsterwerda, Brandenburg, Germany

Gransee, Brandenburg, Germany

Ketzin, Brandenburg, Germany

Potsdam, Brandenburg, Germany

Frankfurt am Main, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Hanau, Hesse, Germany

Kelkheim, Hesse, Germany

Rotenburg an der Fulda, Hesse, Germany

Wetter, Hesse, Germany

Aurich, Lower Saxony, Germany

Bockenem, Lower Saxony, Germany

Braunschweig, Lower Saxony, Germany

Horneburg, Lower Saxony, Germany

Jühnde, Lower Saxony, Germany

Loxstedt, Lower Saxony, Germany

Nienburg, Lower Saxony, Germany

Northeim, Lower Saxony, Germany

Papenburg, Lower Saxony, Germany

Stuhr, Lower Saxony, Germany

Wardenburg, Lower Saxony, Germany

Weyhe, Lower Saxony, Germany

Winsen, Lower Saxony, Germany

Aachen, North Rhine-Westphalia, Germany

Aachen, North Rhine-Westphalia, Germany

Arnsberg, North Rhine-Westphalia, Germany

Bad Lippspringe, North Rhine-Westphalia, Germany

Bad Salzuflen, North Rhine-Westphalia, Germany

Bad Salzuflen, North Rhine-Westphalia, Germany

Bad Sassendorf, North Rhine-Westphalia, Germany

Bergkamen, North Rhine-Westphalia, Germany

Bochum, North Rhine-Westphalia, Germany

Cologne, North Rhine-Westphalia, Germany

Dortmund, North Rhine-Westphalia, Germany

Dortmund, North Rhine-Westphalia, Germany

Dortmund, North Rhine-Westphalia, Germany

Duisburg, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Freudenberg, North Rhine-Westphalia, Germany

Greven, North Rhine-Westphalia, Germany

Hamm, North Rhine-Westphalia, Germany

Hünxe, North Rhine-Westphalia, Germany

Kamp-Lintfort, North Rhine-Westphalia, Germany

Krefeld, North Rhine-Westphalia, Germany

Langenfeld, North Rhine-Westphalia, Germany

Lienen, North Rhine-Westphalia, Germany

Lippetal, North Rhine-Westphalia, Germany

Löhne, North Rhine-Westphalia, Germany

Marl, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Netphen, North Rhine-Westphalia, Germany

Porta Westfalica, North Rhine-Westphalia, Germany

Remscheid, North Rhine-Westphalia, Germany

Siegen, North Rhine-Westphalia, Germany

Viersen, North Rhine-Westphalia, Germany

Welver, North Rhine-Westphalia, Germany

Wetter, North Rhine-Westphalia, Germany

Witten, North Rhine-Westphalia, Germany

Kallstadt, Rhineland-Palatinate, Germany

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Mainz, Rhineland-Palatinate, Germany

Mainz, Rhineland-Palatinate, Germany

Nassau, Rhineland-Palatinate, Germany

Rhaunen, Rhineland-Palatinate, Germany

Speyer, Rhineland-Palatinate, Germany

Beucha, Saxony, Germany

Borna, Saxony, Germany

Delitzsch, Saxony, Germany

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Leipzig, Saxony, Germany

Markkleeberg, Saxony, Germany

Meissen, Saxony, Germany

Oberwiesenthal, Saxony, Germany

Riesa, Saxony, Germany

Wermsdorf, Saxony, Germany

Bitterfeld-Wolfen, Saxony-Anhalt, Germany

Halle, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Bad Bramstedt, Schleswig-Holstein, Germany

Reinfeld, Schleswig-Holstein, Germany

Apolda, Thuringia, Germany

Blankenhain, Thuringia, Germany

Grimma, Thuringia, Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Daaden, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Rehburg-Loccum, , Germany

Riede, , Germany

Thedinghausen, , Germany

Bishopstown, Cork, Ireland

Kilmallock, Limerick, Ireland

Rathkeale, Limerick, Ireland

Tallow, Waterford, Ireland

Enniscorthy, Wexford, Ireland

Gorey, Wexford, Ireland

Bray, Wicklow, Ireland

Cork, , Ireland

Dublin, , Ireland

Chieti, Abruzzo, Italy

Foggia, Apulia, Italy

Amandola, Ascoli Piceno, Italy

Napoli, Campania, Italy

Reggio Emilia, Emilia-Romagna, Italy

Chiavari, Genova, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Como, Lombardy, Italy

Varese, Lombardy, Italy

Legnano, Milano, Italy

Novara, Piedmont, Italy

Turin, Piedmont, Italy

Catania, Sicily, Italy

Chieri, Torino, Italy

Moncalieri, Torino, Italy

Grosseto, Tuscany, Italy

Asti, , Italy

Bergamo, , Italy

Reggio Emilia, , Italy

Bialystok, , Poland

Bydgoszcz, , Poland

Bydgoszcz, , Poland

Chrzanów, , Poland

Czechowice-Dziedzice, , Poland

Elblag, , Poland

Gdansk, , Poland

Gdansk, , Poland

Gdansk, , Poland

Gdynia, , Poland

Gliwice, , Poland

Grodzisk Mazowiecki, , Poland

Katowice, , Poland

Katowice, , Poland

Krakow, , Poland

Krakow, , Poland

Krakow, , Poland

Krakow, , Poland

Krakow, , Poland

Krakow, , Poland

Kutno, , Poland

Linia, , Poland

Lodz, , Poland

Lublin, , Poland

Lublin, , Poland

Lublin, , Poland

Malbork, , Poland

Małaszewicze, , Poland

Nakło nad Notecią, , Poland

Olkusz, , Poland

Ostrów Wielkopolski, , Poland

Poznan, , Poland

Przeworsk, , Poland

Radom, , Poland

Skierniewice, , Poland

Skierniewice, , Poland

Sobótka, , Poland

Sopot, , Poland

Szczyrk, , Poland

Warsaw, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wąbrzeźno, , Poland

Wejherowo, , Poland

Wola, , Poland

Wroclaw, , Poland

Wroclaw, , Poland

Włocławek, , Poland

Zabrze, , Poland

Łańcut, , Poland

Guaynabo, , Puerto Rico

Manatí, , Puerto Rico

Orocovis, , Puerto Rico

San Juan, , Puerto Rico

Trujilo Alto, , Puerto Rico

Sobrado Dos Monxes, A Coruña, Spain

La Roda, Albacete, Spain

Benidorm, Alicante, Spain

Elche, Alicante, Spain

Petrel, Alicante, Spain

Xixona, Alicante, Spain

Vic (Barcelona), Catalonia, Spain

Begonte, Lugo, Spain

Viveiro, Lugo, Spain

Espinardo, Murcia, Spain

Ourense, Ourense, Spain

Oviedo, Principality of Asturias, Spain

Oviedo, Principality of Asturias, Spain

Posada de Llanes, Principality of Asturias, Spain

Gümar, Santa Cruz De Tenerife, Spain

La Victoria, Santa Cruz De Tenerife, Spain

Alcover, Tarragona, Spain

Albacete, , Spain

Alicante, , Spain

Badajoz, , Spain

Barcelona, , Spain

Barcelona, , Spain

Barcelona, , Spain

Huelva, , Spain

León, , Spain

León, , Spain

Lugo, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Murcia, , Spain

Murcia, , Spain

Murcia, , Spain

Salamanca, , Spain

Santander, , Spain

Valladolid, , Spain

Ballymena, Antrim, United Kingdom

Ballymena, Antrim, United Kingdom

Crumlin, Antrim, United Kingdom

Newtonabbey, Antrim, United Kingdom

Craigavon, Armagh, United Kingdom

Bath, Avon, United Kingdom

Bath, Avon, United Kingdom

Radstock, Avon, United Kingdom

Irvine, Ayrshire, United Kingdom

Luton, Bedfordshire, United Kingdom

Slough, Berkshire, United Kingdom

Ely, Cambridgeshire, United Kingdom

Ely, Cambridgeshire, United Kingdom

Peterborough, Cambridgeshire, United Kingdom

Peterborough, Cambridgeshire, United Kingdom

Sandbach, Cheshire, United Kingdom

Boscastle, Cornwall, United Kingdom

Fowey, Cornwall, United Kingdom

Penzance, Cornwall, United Kingdom

Penzance, Cornwall, United Kingdom

Penzance, Cornwall, United Kingdom

Saltash, Cornwall, United Kingdom

St Austell, Cornwall, United Kingdom

Chesterfield, Derbyshire, United Kingdom

Dronfield, Derbyshire, United Kingdom

Plymouth, Devon, United Kingdom

Carryduff, Down, United Kingdom

Annan, Dumfries And Galloway, United Kingdom

Bishop Auckland, Durham, United Kingdom

Darlington, Durham, United Kingdom

Darlington, Durham, United Kingdom

Darlington, Durham, United Kingdom

Leigh-on-Sea, Essex, United Kingdom

Tiptree, Essex, United Kingdom

High Valleyfield, Fife, United Kingdom

Glasgow, Glasgow City, United Kingdom

Bangor, Gwynedd, United Kingdom

Hitchin, Hertfordshire, United Kingdom

Letchworth Garden City, Hertfordshire, United Kingdom

Letchworth Garden City, Hertfordshire, United Kingdom

Canterbury, Kent, United Kingdom

Chestfield, Kent, United Kingdom

Whitstable, Kent, United Kingdom

Carstairs, Lanarkshire, United Kingdom

Coatbridge, Lanarkshire, United Kingdom

Forth, Lanarkshire, United Kingdom

Blackpool, Lancashire, United Kingdom

Blackpool, Lancashire, United Kingdom

Bolton, Lancashire, United Kingdom

Bolton, Lancashire, United Kingdom

Hinckley, Leicestershire, United Kingdom

Wells-next-the-Sea, Norfolk, United Kingdom

Wymondham, Norfolk, United Kingdom

Antrim, North Ireland, United Kingdom

Antrim, North Ireland, United Kingdom

Antrim, North Ireland, United Kingdom

Tyrone, North Ireland, United Kingdom

Wellingborough, Northamptonshire, United Kingdom

Chipping Norton, Oxfordshire, United Kingdom

Eccles, Sheffield, United Kingdom

Bath, Somerset, United Kingdom

Barry, SOuth Glamorgan, United Kingdom

Doncaster, South Yorkshire, United Kingdom

Sheffield, South Yorkshire, United Kingdom

Chapelhall, Stratchclyde, United Kingdom

Glasgow, Stratchclyde, United Kingdom

Hamilton, Stratchclyde, United Kingdom

Johnstone, Stratchclyde, United Kingdom

Motherwell, Stratchclyde, United Kingdom

Bury Saint Edmonds, Suffolk, United Kingdom

Bury St Edmunds, Suffolk, United Kingdom

Bury St Edmunds, Suffolk, United Kingdom

Hadleigh, Suffolk, United Kingdom

Stowmarket, Suffolk, United Kingdom

Addlestone, Surrey, United Kingdom

East Horsley, Surrey, United Kingdom

Worcester Park, Surrey, United Kingdom

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Coventry, Warwickshire, United Kingdom

Coventry, Warwickshire, United Kingdom

Rugby, Warwickshire, United Kingdom

Coventry, West Midlands, United Kingdom

Brighton, West Sussex, United Kingdom

Crawley, West Sussex, United Kingdom

Crawley, West Sussex, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Leeds, West Yorkshire, United Kingdom

Bradford-on-Avon, Wiltshire, United Kingdom

Chippenham, Wiltshire, United Kingdom

Chippenham, Wiltshire, United Kingdom

Corsham, Wiltshire, United Kingdom

Trowbridge, Wiltshire, United Kingdom

Westbury, Wiltshire, United Kingdom

Aberdeen, , United Kingdom

Airedire, , United Kingdom

Antrim, , United Kingdom

Bath, , United Kingdom

Bath, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Belfast, , United Kingdom

Bellshill, , United Kingdom

Blantyre, , United Kingdom

Cardiff, , United Kingdom

Coatrbridge, , United Kingdom

Crossgar, , United Kingdom

Doncaster, , United Kingdom

Dundee, , United Kingdom

Glasgow, , United Kingdom

Glasgow, , United Kingdom

Glasgow, , United Kingdom

Glasgow, , United Kingdom

Hamilton, , United Kingdom

Hamilton, , United Kingdom

Inverness, , United Kingdom

Ipswich, , United Kingdom

Lockerbie, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

New Stevenson, , United Kingdom

Paisley, , United Kingdom

Peterborough, , United Kingdom

Thornhill, , United Kingdom

Watford, , United Kingdom

Wishaw, , United Kingdom

Witley Bay, , United Kingdom

Countries

United States; Germany; Ireland; Italy; Poland; Puerto Rico; Spain; United Kingdom

References

Gaziano JM, Brotons C, Coppolecchia R, Cricelli C, Darius H, Gorelick PB, Howard G, Pearson TA, Rothwell PM, Ruilope LM, Tendera M, Tognoni G; ARRIVE Executive Committee. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial. Lancet. 2018 Sep 22;392(10152):1036-1046. doi: 10.1016/S0140-6736(18)31924-X. Epub 2018 Aug 26.

Reference Type: RESULT

PMID: 30158069 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2006-003622-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12198

Identifier Type: -

Identifier Source: org_study_id