SYNCHRONIZE-CVOT — structured trial abstract
SYNCHRONIZE-CVOT — Survodutide in cardiovascular and obesity: event-driven cardiovascular outcome trial
§1Structured abstract
§1.1Objective
To evaluate Survodutide in atherosclerotic cardiovascular disease and cardiovascular risk reduction and obesity and overweight in adults, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- not recorded by the Institute
- Duration of the primary analysis period
- Event-driven
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Time to first major adverse cardiovascular event
§1.4Principal result
The trial was ongoing at the assessment date. The Institute publishes no effect estimate for an unreported trial and does not reproduce a figure announced by a sponsor before publication. The reasoning is recorded in the methodology document.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Not held | Not recorded by the Institute. The field is left empty rather than estimated. |
| Principal result | Not held | No result is reproduced. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |