NCT04634162: SWAP-5

PD and PK Profiles of Switching Between Cangrelor and Ticagrelor Following Ticagrelor Pre-treatment

Completed Phase 4 Results posted Last updated 16 May 2023

What this trial tests

Phase 4 trial testing Cangrelor in Coronary Artery Disease in 22 participants. Completed in 30 November 2021.

Timeline

9 February 2021

Primary endpoint
16 August 2021

30 November 2021

Quick facts

Lead sponsor	University of Florida
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	22
Start date	9 February 2021
Primary completion	16 August 2021
Estimated completion	30 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Cangrelor (CANGRELOR) — full drug profile →
• Placebo

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University of Florida

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Platelet Reactivity Measured by VerifyNow Primary · 2 hours

The primary end point of the study will be the non-inferiority in P2Y12 reaction units (PRU) measured by VerifyNow after discontinuation of cangrelor vs. placebo

Group	Value	95% CI
Cangrelor	16.9	-11.8 – 45.7
Placebo	12.6	-16.1 – 41.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cangrelor

Serious: 0/20 (0%)

Deaths: 0/20

Placebo

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Cangrelor	Placebo
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT04634162 adverse events section.

Sponsor's own description

Cangrelor is an intravenous P2Y12 inhibitor utilized as a bridge to achieve adequate platelet inhibition until oral P2Y12 inhibitors achieve their full antiplatelet effects in patients undergoing coronary stenting. Although in this setting the potent oral P2Y12 inhibitor ticagrelor is commonly utilized, there is very limited data on the optimal approach for switching between these therapies. The methodological approach for this assessment should rely on comprehensive pharmacodynamics (PD) investigations aimed to assess levels of P2Y12 receptor inhibition, pharmacokinetic (PK) investigations to assess systemic levels of the drug/drug metabolite, and mechanistic investigations by assessment of levels of P2Y12 receptor gene expression. The overarching aim of this investigation is to rule out a drug-drug interaction when ticagrelor is administered prior to cangrelor infusion.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cangrelor: Clinical Data, Contemporary Use, and Future Perspectives.
   De Luca L, Steg PG, Bhatt DL, Capodanno D, et al · · 2021 · cited 62× · PMID 34212768 · DOI 10.1161/jaha.121.022125
2. Cangrelor in Patients With Coronary Artery Disease Pretreated With Ticagrelor: The Switching Antiplatelet (SWAP)-5 Study.
   Franchi F, Ortega-Paz L, Rollini F, Galli M, et al · · 2023 · cited 22× · PMID 36317958 · DOI 10.1016/j.jcin.2022.10.034
3. Pharmacodynamic effects of cangrelor in elective complex PCI: insights from the POMPEII Registry.
   Gargiulo G, Marenna A, Sperandeo L, Manzi L, et al · · 2023 · cited 12× · PMID 36512429 · DOI 10.4244/eij-d-22-00594
4. The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
   Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w