The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

However, due to safety concerns, physicians are often hesitant to prescribe the nicotine patch to patients who have just suffered a heart attack.

It had two arms (groups): Day 1 (active comparator) and Day 2 (active comparator).

Patients randomized to wearing the patch on day 1 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 2.

Patients randomized to wearing the patch on day 2 will apply a patch on the morning of their treatment day and keep it on for 24 hours. These patients will not wear a patch on day 1.

The registry classes the interventions as drug.

More on the Plan

After surviving an ACS, most patients are highly motivated to stop smoking.

Although transdermal nicotine more than doubles long-term smoking cessation rates when compared with placebo, it is rarely prescribed by physicians in the weeks immediately following an ACS because the possible cardiovascular effects of nicotine after an ACS have yet to be systematically evaluated.

Prior to randomization, all patients will receive standardized smoking cessation counselling.

Subjects who satisfy the inclusion and exclusion criteria for the trial will be randomized within 48 hours of suffering an ACS to wear a transdermal nicotine patch on either day 1 or day 2 of the study period.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 18 years. Current smoker, ≥ 10 cigarettes per day, on average, for the past year. Motivated to quit smoking.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: current use of any medical therapy for smoking cessation; history of severe dermatitis; current diagnosis of unstable psychiatric illness requiring medication.

How the Study Was Run

Design: randomized, crossover and open-label.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Therapeutic nicotine (patch, non-peptide) and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2005-06 with completion listed for 2009-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The total duration of ischemic episodes (time frame: Day 1 and Day 2).

It also tracked 4 secondary outcomes, for example Patient adherence to study protocol, Incidence of arrhythmia, Heart rate and Systolic and diastolic blood pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is suspended; 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.