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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.

Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh CV Risk PatienTs with Hypertriglyceridemia

NCT ID

Patient Level Data

Therapeutic Area

Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)

Research Site

A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)

MACE components include: cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Number of Participants with Event

MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

The composite of Major adverse cardiovascular events (MACE)

Overall number of participants

Number of participants with established cardiovascular disease (CVD) at baseline

The composite of MACE in the subgroup of participants with established CV disease(CVD) at baseline

Number of participants with events

CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

The composite of CV events

Number of participants with established CVD at baseline

The composite of CV events in the subgroup of participants with established CV disease (CVD) at baseline

Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

The composite of coronary events

Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline

The composite of coronary events in the subgroup of participants with established CVD at baseline

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.

CV death

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline

CV death in the subgroup of participants with established CVD at baseline

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.

All-cause death

Number of participants with established CVD at baselne

Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline

All-cause death in the subgroup of participants with established CVD at baseline

Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Emergent/elective coronary revascularization

Hospitalization for unstable angina

Non-fatal myocardial infarction

Non-fatal stroke

Overall Study

AstraZenenca Information Center

The secondary outcome measures will be analyzed the same as outlined above for the primary outcome measures.

The composite measure of coronary events that include the first occurrence of cardiac death ( including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), nonfatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina.

Cardiovascular death includes death resulting from: an acute MI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.

Arms	Assigned Interventions
Experimental: EPANOVA Epanova + statin, once daily	Drug: Epanova® (omega-3 carboxylic acids) Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE) Other Name: omega-3 carboxylic acids
Active Comparator: Corn oil Corn oil + Statin	Drug: corn oil control corn oil control arm Other Name: n/a

Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh CV Risk PatienTs with Hypertriglyceridemia - STRENGTH

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Exclusion Criteria

Documents available

redacted CSP

redacted SAP

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator