Heart and Blood Diseases

All Conditions

Neoplasms

Digestive System Diseases

Vascular Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Herbal and Botanical

Aspirin

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Cola

Patients in Italy who are eligible to use low-dose aspirin for primary prevention of CVD and CRC.

Subgroups:

* Patients eligible for and using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD
* Patients eligible for and not using low-dose aspirin who are at 20% ten-year CVD risk for primary prevention of CVD

Patients in Italy who are eligible to use low-dose aspirin for secondary prevention of CVD and CRC.

Subgroups:

* Patients eligible for and using low-dose aspirin for secondary prevention of CVD
* Patients eligible for and not using low-dose aspirin for secondary prevention of CVD

Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC.

This study does not involve prescription of the drugs. This study is a cross-sectional survey of patients taking low-dose aspirin or patients who are eligible but not taking low-dose aspirin.

Acetylsalicylic acid (Aspirin, BAYE4465)

Research shows that low-dose Aspirin prevents diseases of heart and blood vessels as well as cancer of the colon and rectum and it is also associated with risk of bleeding. In this study, they want to learn how patients regard the benefits and risks of low-dose Aspirin for the prevention of these diseases. The researchers also want to learn how patients balance these risks and benefits.

Study to Evaluate How Patients Regard the Benefits and Risks of Low-dose Aspirin for the Prevention of Heart and Blood Vessels Disease and for the Prevention of Cancer of the Colon and Rectum

Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (Cardiovascular Disease) and CRC (Colorectal Cancer) Prevention

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Using qualitative interviews to assess how patients and physicians perceive the benefits and risks of low-dose aspirin for the prevention of cardiovascular disease (CVD) and colorectal cancer (CRC)

Using quantitative surveys to elicit patients' benefit/risk trade-offs on key efficacy and safety outcomes of low-dose aspirin in CVD and CRC prevention

Quantify the change in likelihood of adverse events (AEs) that patients are willing to accept in order to experience the benefits of low-dose aspirin for CRC and CVD prevention compared to CVD prevention alone

Assess how different subgroups of patients, such as those using low-dose aspirin and those eligible for but not using low-dose aspirin, differ in their preferences

Bayer

Rare Diseases

Stomach Neoplasms

Esophageal Neoplasms

Stomach Cancer

Esophageal Cancer

New-users of low-dose aspirin is defined as patients who did not receive any prescriptions of low-dose aspirin one year prior to the index date.

Users of Paracetamol is defined as patients who receive first prescription of paracetamol during the study period. Since the patients receiving low-dose aspirin are potentially less healthy compared to non-users of aspirin, patients receiving paracetamol as the control group can minimise healthy user bias.

Acetylsalicylic Acid (Aspirin, BAYE4465)

In this study, researchers wanted to learn more about the effect of Aspirin taken as low dose (75 - 300 mg) in preventing stomach, colorectal and esophagus cancer. The researchers were interested in the effect by duration of aspirin use and the effect on the time since aspirin intake has been stopped in preventing stomach, colorectal and esophagus cancer. In addition, the study also looked into the time patients survived after being diagnosed (survival rate) with cancer and number of cancer patients who died (case fatality rate). The study was based on an electronic database managed by the Health Authority in Hong Kong containing anonymized clinical information of patients living in Hong Kong.

Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer

Effectiveness of Low-dose Aspirin in Gastrointestinal Cancer Prevention - Hong Kong

Ratio of incidence (per 10,000 person years) among users of low-dose-aspirin (exposed) and users of paracetamol monotherapy (non-exposed)

Minimum duration of aspirin use to confer the protective effects in preventing colorectal, gastric and esophageal cancer

Logistic regression will be conducted based on nested case-control study with stratification on the recency of exposure with current use, past use, and distant use of aspirin.

For colorectal cancer, gastric or oesophageal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate How Patients Regard the Benefits and Risks of Low-dose Aspirin for the Prevention of Heart and Blood Vessels Disease and for the Prevention of Cancer of the Colon and Rectum	NCT03603366	Cardiovascular ... Colorectal Canc...	Acetylsalicylic...	18 Years - 70 Years	Bayer
Effectiveness of Low Dose Aspirin in Decreasing the Chance Getting Stomach and Intestine Cancer	NCT04081831	Gastrointestina...	Acetylsalicylic...	40 Years -	Bayer

Spots Global Cancer Trial Database for acetylsalicylic acid (aspirin, baye4465)