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| ID | Type | Description | Link |
|---|---|---|---|
| 6517-CL-0020 | Other Identifier | Merck | |
| MK-6621-045 |
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The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.
Participants received a 10-minute intravenous (IV) infusion of vernakalant (3 mg/kg) or an equivalent amount of normal saline (placebo), followed by a 15-minute observation period. If the participant was still in atrial fibrillation or atrial flutter, a second 10-minute IV infusion of vernakalant (2 mg/kg) or an equivalent amount of placebo was administered unless the participant experienced any dose-stopping criteria after the start of the first infusion. If a participant converted to sinus rhythm during the first or second infusion, that infusion was completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vernakalant | Experimental | Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes |
|
| Placebo | Placebo Comparator | Placebo (saline) administered IV at same volume and rate as per dosing schedule for vernakalant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vernakalant | Drug | Maximum volume of 100 mL as per the dosing schedule, administered intravenously (IV) over 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience Hypotension, Ventricular Arrhythmias and/or Death | Hypotension defined as: systolic blood pressure (SBP) <90 mmHg and treated with pressors; SBP <90 mmHg and treated with albumin, dextran or hydroxyethyl starch; or SBP <90 mmHg and seizures. Ventricular arrhythmias defined as: Sustained ventricular tachycardia with a heart rate of >120 beats per minute. Sustained tachycardia defined as lasting >30 seconds; Torsade de Pointes with a duration of >10 seconds; Ventricular fibrillation of any duration. | Occurring within the first two hours after start of study treatment |
| Number of Participant with Successful Conversion to Sinus rhythm (SR) | Successful conversion defined as return to sinus rhythm for at least 1 minute documented by Holter electrocardiogram (ECG) or by two consecutive 12-lead ECGs recorded > 1 minute apart within 90 minutes of first exposure to study treatment | Occurring within 90 minutes of first exposure to study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time from First Exposure to Study Treatment to Conversion of AF to SR | Occurring within 90 minutes after study treatment | |
| Number of Participants who Report No Symptoms | Participant was considered a success (no symptoms) if they did not have any of the following symptoms at 90 minutes: palpitations, dyspnea, dizziness, chest pain or fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27233239 | Derived | Beatch GN, Mangal B. Safety and efficacy of vernakalant for the conversion of atrial fibrillation to sinus rhythm; a phase 3b randomized controlled trial. BMC Cardiovasc Disord. 2016 May 28;16:113. doi: 10.1186/s12872-016-0289-0. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C524581 | vernakalant |
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| Placebo | Drug | Injection |
|
| Occurring 90 minutes after first exposure to study treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |