Helios Cardio · CV-118
Reduction of MACE in post-MI patients with elevated Lp(a)
Event-driven CV outcomes Ph3. All randomisation complete; in long-term follow-up. Event accrual is on plan and interim analysis 2 closed with DSMB recommendation to continue unchanged.
Sit-rep
Status
Follow-up
Health
On track
Forecast end
Jul 5, 2027
+5d vs plan
Projected EAC
112.0M USD
+500k USD vs contract
Live activity
No activity yetKey performance indicators
Threshold colour is supplementary to the on-target / at-risk / breached label.
- Enrolment
- 8,400 / 8,400 (100%)
- Screen failure rate
- 28%
- Query aging (>14d)
- 34 open
- Protocol deviations
- 212
- Adjudicated MACE
- 1,141 / 1,260
- Loss-to-follow-up
- 3.1%
- Projected DBL variance
- +5 days
- Budget burn
- 84%
- Forecast EAC
- $112M
Timeline & milestones
Bar shows planned span; tick marks current forecast end. Markers are colour-coded by milestone status (labels in tooltip / table below).
| Milestone | Planned | Actual / forecast | Variance | Status |
|---|---|---|---|---|
| FPI | May 15, 2021 | May 22, 2021 | +7d | Complete |
| 25% enrolment | Mar 30, 2022 | Apr 12, 2022 | +13d | Complete |
| 50% enrolment | Dec 15, 2022 | Dec 4, 2022 | -11d | Complete |
| 75% enrolment | Aug 30, 2023 | Sep 8, 2023 | +9d | Complete |
| LPI | May 15, 2024 | May 21, 2024 | +6d | Complete |
| LPLV | Sep 30, 2026 | Oct 5, 2026 | +5d | In progress |
| Database lock | Dec 30, 2026 | Jan 4, 2027 | +5d | Planned |
| CSR draft | Mar 15, 2027 | Mar 20, 2027 | +5d | Planned |
| CSR final | Jun 30, 2027 | Jul 5, 2027 | +5d | Planned |
| Severity | Title | Owner | Mitigation | Status |
|---|---|---|---|---|
| Low | Event rate slightly below DSMB-projected curve | Biostatistics Lead | On track per pre-specified contingency; LPLV trigger by event count, not date. | Mitigating |
| Medium | CSR authoring vendor capacity over Q1 2027 | Medical Writing Lead | Backup author identified; CSR shell pre-built. | Mitigating |
| Low | Long-tail subject retention in Eastern Europe | CRA Manager | Retention stipend uplift approved; LTFU still 3.1%, below 4% threshold. | Mitigating |
Resources
| Role | Headcount | FTE | Monthly rate | Monthly cost |
|---|---|---|---|---|
| CRA | 22 | 14.0 | 20k USD | 277k USD |
| Data Management | 8 | 6.0 | 16k USD | 97k USD |
| Pharmacovigilance | 5 | 3.0 | 19k USD | 57k USD |
| Biostatistics | 5 | 4.2 | 23k USD | 97k USD |
| Medical Writing | 3 | 1.5 | 20k USD | 30k USD |
| Endpoint Adjudication | 4 | 1.4 | 25k USD | 34k USD |
| Total | 47 | 30.1 | — | 592k USD |
Financials
Contracted budget
111.5M USD
EBV spent
93.7M USD
84% of contract
EAC (estimate at completion)
112.0M USD
+500k USD vs contract
Burn vs time elapsed
84% / 83%
broadly aligned
Recent activity
Provenance events (24h)
643
Staging items pending
5
Signatures (7d)
38
View provenance for this study →View staged records for this study →
Study goals
Reach 1,260 adjudicated MACE before LPLV
Maintain < 4% loss-to-follow-up across all regions
Hold DBL within 90 days of LPLV
Deliver topline read-out for the next AHA scientific session