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Aggressive Smoking Cessation for Acute Coronary Syndrome (ASAP Trial)
ASAP Trial Summary
This trialwill assess if aggressive smoking cessation therapy given in-hospital to smokers with ACS helps them quit for good.
ASAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASAP Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ASAP Trial Design
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Who is running the clinical trial?
Media Library
- You have a mental health condition that is not currently well-managed.I can start varenicline in the hospital and use a nicotine e-cigarette after my heart procedure.You have used nicotine or non-nicotine e-cigarettes in the 30 days before being admitted to the hospital for acute coronary syndrome.I have severe heart disease with symptoms and changes seen in tests during this hospital stay.I am willing and able to buy specific e-cigarettes if needed for the study.My heart condition severely limits my daily activities.You have used illegal drugs in the past year.I can understand and consent in English or French.I have used medication to quit smoking in the last 30 days.I was hospitalized for a heart attack with specific heart enzyme levels and ECG changes.I have smoked at least one cigarette a day for the past year.You want to quit smoking and have a high level of motivation according to a scale called the Motivation To Stop Scale.I have used varenicline or e-cigarettes for 2 weeks or more in the last year.I am 18 years old or older.I plan to use cannabis or tobacco products during the study.I haven't taken any anti-craving medication in the last 30 days.You had a bad reaction to varenicline or e-cigarettes in the past.My kidney function is severely impaired.
- Group 1: Varenicline Plus Counseling
- Group 2: Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are being recruited for this experiment?
"Affirmative. Clinicaltrials.gov hosts the latest information about this ongoing trial, which was first published on October 31st 2022 and recently updated on November 1st 2022. At present, 798 individuals need to be enrolled from a solitary medical centre."
Is there presently any availability for patients to join this trial?
"Accurate. According to the information on clinicaltrials.gov, this medical study is recruiting patients right now. It was initially posted on October 31st 2022 and most recently updated a day later. The objective is to recruit 798 people from a single site."
Has the Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) achieved regulatory clearance from the FDA?
"Combination Therapy Arm (Varenicline and Nicotine E-Cigarettes Plus Counseling) has been extensively tested, so it was assigned a rating of 3 on our risk scale. This signifies that there is substantial evidence supporting the treatment's efficacy and safety."
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