Early In-hospital Initiation of Pharmacotherapy for Smoking Cessation, Concomitant With Nurse-Led Support, in Patients After an Acute Coronary Syndrome (ACS)

NCT02106637 NA UNKNOWN

The hypothesis of this study is that combination of Varenicline treatment with nurse-led hospital support during hospitalization and after discharge will result in clinically significant higher long term abstinence rates in smokers with ACS, as compared with nurse led support and placebo, without a significant increase in the risk of adverse events.

Details

Lead sponsor	Sheba Medical Center
Phase	NA
Status	UNKNOWN
Enrolment	300
Start date	2016-10
Completion	2018-12

Conditions

• Acute Coronary Syndrome
• Smoking Cessation

Interventions

• Varenicline
• placebo

Primary outcomes

• Primary efficacy and Safety endpoint: — within 12 month from enrollment
  Continuous abstinence rate (CAR) from smoking 1-year after hospitalization as determined by self-reporting and verified by CO testing. Only the combination of the two will be considered as achieving CAR . Non inferior serious adverse event (SAE) rate, defined as: event rate in the intervention group compared to the placebo (SAE according to the FDA definitions) group at 12 months. An interim analysis will be preformed after 33% and 66% of patients have been finished the follow-up duration.

Countries

Israel