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

An observational study of Cardiovascular Disease and Colorectal Cancer, run by Bayer at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cardiovascular Disease, Colorectal Cancer
What is being tested?: Acetylsalicylic acid (Aspirin, BAYE4465)
How many people: 1,028 participants
Where: 1 siteItaly
Study dates: 14 Aug 2019to 14 Oct 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Many locations
Multiple Locations

Other trials in Italy

About this study

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

Conditions: Cardiovascular Disease, Colorectal Cancer
Being tested: Acetylsalicylic acid (Aspirin, BAYE4465)
Medical subject headings: Cardiovascular Diseases, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Also called Low-dose Aspirin
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.

Study groups in NCT03603366
Study group	Role	What they receive
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 Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
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 Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Physicians		Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC.

What is being measured

The primary outcome is the main question the study is designed to answer.

Perceive of low dose aspirin
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)
Measured: Up to 1 hour
Patients' benefit/risk trade-offs
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
Measured: Up to 1 hour

Secondary outcomes (2)

Change in likelihood of AEs
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
Measured: Up to 1 hour
Preferences of aspirin using in different subgroups
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
Measured: Up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 201914 Oct 2019

First posted27 Jul 2018
Study start14 Aug 2019
Primary completion14 Oct 2019
Study completion14 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by BayerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 1,028 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03603366
Sponsor's protocol ID: 20211
Status last verified: Sep 2020
First submitted: 20 Jul 2018
Last updated: 5 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-centred Benefit-risk Observational Study of Low-dose Aspirin for CVD (Cardiovascular Disease) and CRC (Colorectal Cancer) Prevention
ClinicalTrials.gov ID: NCT03603366
Acronym / sponsor ID: 20211
Conditions: Cardiovascular Disease, Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 1,028 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 14 Aug 2019 (actual)
Primary completion: 14 Oct 2019 (actual)
Study completion: 14 Oct 2019 (actual)
First posted: 27 Jul 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 3

Arm	Type	Receives
Primary prevention	–	Drug: Acetylsalicylic acid (Aspirin, BAYE4465)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
Secondary prevention	–	Drug: Acetylsalicylic acid (Aspirin, BAYE4465)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	–	–Physicians from Italy with experience recommending low-dose aspirin for primary and/or secondary prevention of CVD and CRC.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (19 listed)

Age and CVD characteristics
Able to read and understand Italian
No participation in an investigational program with interventions outside of routine clinical practice
For qualitative interviews:
For pilot/cognitive interviews :

Key exclusion criteria (18 listed)

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)
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acetylsalicylic acid (Aspirin, BAYE4465)Also: Low-dose AspirinThis 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.	Drug	Primary prevention, Secondary prevention

Primary outcome

Perceive of low dose aspirin
Time frame: Up to 1 hour
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)
Patients' benefit/risk trade-offs
Time frame: Up to 1 hour
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

2 secondary outcomes

Change in likelihood of AEs
Time frame: Up to 1 hour
Preferences of aspirin using in different subgroups
Time frame: Up to 1 hour

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
Individual participant dataSharing planned: Undecided. 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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Heart Failure
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RecruitingPhase 1/2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Disease and Colorectal Cancer, run by Bayer at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceive of low dose aspirin (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.