Table 1.
RAPS trial assessment schedule
| Assessment (Procedure/activity) | Screening | Baseline | Visit 1 Day 42 (ideally -12days+14 days) | Visit 2 Day 90 (ideally±14days) | Visit 3 Day 180 (ideally±14days) | Visit 4 Day 210 (ideally±14days) |
|---|---|---|---|---|---|---|
| Consent | X | |||||
| Medical History | X | |||||
| Demographics | X | |||||
| Patient review | X | X | X | X | X | X |
| Height | X | |||||
| Weight | X | X | ||||
| BMI | X | X | ||||
| Blood pressure | X | X | ||||
| FBC | X | X | ||||
| U&E, CrCl | X | X | ||||
| LFTs | X | X | ||||
| Anti-DNA | X | |||||
| aPL | X | |||||
| 20 mL citrated blood sample for trial assessments (all patients) | X | X | ||||
| 20 mL blood sample for the translational research (optional) | X | X | ||||
| Pregnancy tests | X | X | X | |||
| Current medication | X | X | X | X | X | X |
| Document INRs | X | X | X | X | ||
| Dispensation rivaroxaban | X | X | ||||
| Drug accountability of rivaroxaban | X | X | X | |||
| Enquiry for bleeding symptoms | X | X | X | X | X | X |
| Enquiry for recurrent thrombosis | X | X | X | X | X | X |
| QoL questionnaire | X | X |
Timing of screening tests:
The following tests are repeated if screening was more than 14 days prior to randomization:
Full blood count (FBC)
Urea and electrolytes (U&E) and creatinine clearance (CrCl) (to be calculated using the Cockcroft & Gault formula)
Liver function tests (LFTs) to include ALT
*Anti-DNA tests no more than three months prior to randomization, i.e. testing for anti-DNA is not required within 30 days prior to randomisation
**Patients are diagnosed with thrombotic APS (defined in Appendix C) prior to trial entry. Results and dates of routine aPL tests establishing a diagnosis of thrombotic APS are documented in the CRF (i.e. testing for aPL is not required within 30 days prior to randomisation). aPL are reassessed at baseline using established methods,50–54 to define aPL status at trial entry (Appendix E).
+INR to be performed only in patients randomised to remain on warfarin