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Trial record 1 of 252 for:    ASPIRIN AND low-dose aspirin
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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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03603366
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Disease, Colorectal Cancer Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

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Study Type : Observational
Estimated Enrollment : 1023 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (Cardiovascular Disease) and CRC (Colorectal Cancer) Prevention
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Group/Cohort Intervention/treatment
Primary prevention

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
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
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.
Other Name: Low-dose Aspirin

Secondary prevention

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
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
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.
Other Name: Low-dose Aspirin

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



Primary Outcome Measures :
  1. Patients preferences regarding low-dose aspirin using a discrete choice experiment [ Time Frame: approximately 30 minutes ]
    Potentially eligible patients will be invited to participate in the survey by the research panel.

  2. Patients understanding regarding benefits and risks of low-dose aspirin using a qualitative phone or in-person interviews [ Time Frame: approximately 1 hour ]
    This interview is designed to gain an in-depth understanding of patient perspectives of the benefits and risks of low-dose aspirin, including for CRC prevention.

  3. Physicians understanding regarding benefits and risks while prescribing low-dose aspirin by using a qualitative phone or in-person interviews [ Time Frame: approximately 1 hour ]
    Based on their clinical experiences—to understand the key aspects while prescribing low-dose aspirin for CVD and CRC prevention, and the safety profile of low-dose aspirin.



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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who are eligible for and/or taking low-dose aspirin will be recruited for qualitative interviews, pilot/cognitive interviews, and the main quantitative survey. Medically trained physicians who have experience prescribing low-dose aspirin for CVD (cardiovascular disease) and CRC (colorectal cancer) prevention will be eligible for the qualitative interviews.
Criteria

Patient Eligibility Criteria

Inclusion Criteria:

  • Age and CVD characteristics

    • Primary prevention:

      • 50-70 years of age
      • Self-report clinical characteristics that result to 20% or higher, 10-year risk of CVD based on the Progetto Cuore scores
    • Secondary prevention:

      • 18 years or older
      • Having a self-reported history of CV event (e.g., myocardial infarction (MI), ischaemic stroke or Transient Ischaemic stroke, , and angina)
  • Able to read and understand Italian
  • No participation in an investigational program with interventions outside of routine clinical practice
  • For qualitative interviews:

    • Willing and able to provide (electronic) informed consent to participate in the study
    • Willing and able to participate in a telephone interview, and to be audio-recorded
  • For pilot/cognitive interviews :

    • Willing and able to complete an online survey
    • Willing and able to provide (electronic) informed consent to participate in the study
    • Willing and able to participate in an in-person interview, and to be audio-recorded
  • For quantitative main survey:

    • Willing and able to complete an online survey
    • Willing and able to provide (electronic) informed consent to participate in the study

Exclusion Criteria:

  • Have glucose-6-phosphate dehydrogenase (G6PD) deficiency (which commonly causes haemolytic anaemia, which is often triggered from eating fava beans, a condition called Favism)
  • Have the following conditions (which are contraindications to low-dose aspirin)

    • Known hypersensitivity to salicylates
    • Known to have had asthma induced by salicylates
    • Having been diagnosed with acute gastroduodenal ulcers
    • Haemorrhagic diathesis
    • Renal failure
    • Hepatic failure
  • Concomitant treatment with methotrexate
  • Cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, or insufficient knowledge of Italian that—in the opinion of the investigator/interviewer—could interfere with a patient's ability to provide written consent and complete an interview or survey
  • To be currently pregnant
  • Are pharmaceutical company employees or employed in a position where they have a direct role in treating patients with CVD

Physician Eligibility Criteria:

  • A medically trained physician
  • Able to read, speak, and understand Italian sufficiently to complete an interview
  • Able to provide informed consent electronically
  • Have at least five year experience prescribing low-dose aspirin for primary and secondary prevention of CVD
  • Willing to be audio-recorded, including adherence to the interview instructions

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 ClinicalTrials.gov identifier (NCT number): NCT03603366


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Italy
Many locations Recruiting
Multiple Locations, Italy
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03603366     History of Changes
Other Study ID Numbers: 20211
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aspirin
Colorectal Neoplasms
Cardiovascular Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics