Sedative Premedication in Coronary Angiography

NCT ID: NCT03576456

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Angiography Sedative Premedication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo controlled, double blind
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alprazolam

Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography.

Group Type ACTIVE_COMPARATOR

Alprazolam 0.5 mg

Intervention Type DRUG

receive alprazolam prior to angio

Placebo Oral Tablet

Patients receive placebo 1 hour prior to coronary angiography.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

receive placebo prior to angio

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alprazolam 0.5 mg

receive alprazolam prior to angio

Intervention Type DRUG

Placebo Oral Tablet

receive placebo prior to angio

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* elective coronary angiography

Exclusion Criteria

* planned PCI
* use of sedative medication at home
* use of alcohol
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wilgenhof Adriaan

Medical Doctor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Danny Schoors, MD PhD

Role: STUDY_DIRECTOR

Head of service

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Adriaan Wilgenhof

Brussels, Jette, Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Adriaan Wilgenhof, MD

Role: CONTACT

003224776009

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adriaan Wilgenhof, MD

Role: primary

003224776009

Xavier Galloo, MD

Role: backup

003224776009

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

awxg2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.