NCT02749279

Brief Summary

The most important drugs for evidence based lipid lowering treatment (LLT) in CHD are statins. All patients with established CHD should be treated with statins irrespective of low density lipoprotein (LDL) cholesterol (LDL-C) levels. The goals of treatment are LDL-C below 1.8 mmol/L (70 mg/dL) or 50% LDL-C reduction when target level cannot be reached. Unfortunately, several patients cannot achieve treatment targets also related to the serious problem of adherence to therapy, which includes also LLT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

August 28, 2019

Status Verified

March 1, 2019

Enrollment Period

3.1 years

First QC Date

April 8, 2016

Last Update Submit

August 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Data collection (Adherence to lipid lowering therapy after cardiac rehabilitation)

    Adherence to lipid lowering therapy after cardiac rehabilitation

    12 Months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with CHD, who will be admitted for cardiac rehabilitation to the participating German rehabilitation clinics and in whom LLT is indicated will be included. Written informed consent will be obtained from each participant. Beginning of the study is 1st May 2016, the inclusion of the last patient is expected on 30th April 2016. Follow-up: at 3 and 12 months, respectively, inclusion of 100 participants per clinic is expected.

You may qualify if:

  • Lipid lowering therapy after cardiac rehabilitation

You may not qualify if:

  • Inability or refusal to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paracelsus Harz Clinic Bad Suderode

Quedlinburg, Saxony-Anhalt, 06485, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 22, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2019

Study Completion

September 1, 2020

Last Updated

August 28, 2019

Record last verified: 2019-03

Locations