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Smoking Cessation After Acute Coronary Syndrome
Plain-language guide to NCT03209622: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 89 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03209622
- Phase
- not phased
- Status
- completed
- Start
- 2015-01-02
- Completion (planned or actual)
- 2017-11-01
- Participants
- 89 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Smoking; Acute Coronary Syndrome; Recurrence
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).
All smokers Hospitalized for ACS were included.
Participants were randomly assigned to either group "A", initiating Nicotine replacement therapy (NRT) in intra-hospitalization or a control group "B" that received NRT after hospital discharge.
It had two arms (groups): A intervention (experimental) and B: control (active comparator).
The registry classes the interventions as drug, other and procedure.
More on the Plan
It is a major and independent risk factor for coronary heart disease (CHD) (2).
So, being hospitalized for a major cardiac condition, such as ACS can be an opportunity to prompt many individuals to stop smoking.
However, the smoking cessation remains a secondary concern in cardiology departments and there is no well strategies offered to these smoker patients with established CHD.
The researchers aimed at comparing, among patients with ACS, the smoking cessation rates with NRT when began in-hospitalization, against that began after hospital discharge. 1.
Who Took Part
89 actual participants took part.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.
The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.
It started in 2015-01-02 with completion listed for 2017-11-01.
It ran at 1 site in Tunisia.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: smoking cessation rates with NRT among patients hospitalized for acute coronary syndrome (time frame: 24 weeks after acute coronary syndrome).
It also tracked 1 secondary outcome, for example smoking cessation duration with NRT among patients hospitalized for acute coronary syndrome.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 89 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.
Our Notes on the Compound
Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.