NCT04069598

Brief Summary

Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

August 23, 2019

Last Update Submit

September 10, 2019

Conditions

Statin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Statin intolerance

    Number (percentage) of patients with statin intolerance

    6 months

Interventions

Statin intolerance testDIAGNOSTIC_TEST

Statin intolerance test

Eligibility Criteria

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

Acute coronary syndrome patients

You may qualify if:

  • Acute coronary syndrome

You may not qualify if:

  • Being on statin, having statin related side effects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haseki

Istanbul, Turkey (Türkiye)

RECRUITING

Siyami Ersek

Istanbul, Turkey (Türkiye)

RECRUITING

Tepecik

Izmir, Turkey (Türkiye)

RECRUITING

Ozcan Basaran

Muğla, 48000, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

August 26, 2019

Primary Completion

March 2, 2020

Study Completion

March 31, 2020

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

TU(4)