NCT03357874: TROUPER

TicagRelor Or Clopidogrel in Severe and Terminal Chronic Kidney Disease Patients Undergoing PERcutaneous Coronary Intervention for an Acute Coronary Syndrome.

Completed Phase 3 Last updated 27 June 2025

What this trial tests

Phase 3 trial testing Clopidogrel in Acute Coronary Syndrome in 259 participants. Completed in 18 July 2023.

Timeline

28 October 2018

Primary endpoint
1 January 2023

18 July 2023

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	259
Start date	28 October 2018
Primary completion	1 January 2023
Estimated completion	18 July 2023
Sites	1 location across France

Drugs / interventions tested

• Clopidogrel (clopidogrel) — full drug profile →
• Ticagrelor (ticagrelor) — full drug profile →

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

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

Sponsor's own description

Ticagrelor is a potent and fast-acting P2Y12-ADP receptor antagonist recommended as first-line agent in ACS (2). This drug was associated with a 20% relative reduction in the rate of MACE in ACS patients undergoing PCI compared to clopidogrel. This benefit came without any increase in major bleedings compared to clopidogrel (6).

In the PLATO trial, a limited number of kidney failure patients were included (21%) and patients with terminal CKD were excluded. A sub-group analysis focused on CKD patients was performed. Only 214 patients with CKD below stage 4 (creatinine clearance \<30 ml/min) were included (7). No patient with terminal CKD or undergoing chronic hemodialysis was included.

Of importance, kidney function impairment is frequent and affects up-to 40 % of ACS patients. In addition, CKD is a powerful independent predictor of ischemic complications during ACS (8-9).Indeed, CKD patients have a very high risk of MACE following ACS with an odd ratio between 2 and 3 compared to patients with normal kidney function and event rates above 40% at one year follow-up (8-13). Of importance these patients more often have high on-clopidogrel platelet reactivity which was strongly associated with a worse clinical outcome (3,14-16). In CKD patients HTPR was associated with death after PCI (15). Accordingly ticagrelor which overcomes these limitations of clopidogrel could be associated with a major clinical benefit in severe or terminal CKD patients.

Most of ticagrelor and is active metabolites are excreted through the feces. Preclinical data suggested that renal impairment had little effect on systemic exposure to the drug(EMEA/H/C/1241 (28)). Recent pharmacodynamic and kinetic studies confirmed these preclinical data on the safety of ticagrelor in severe and end-stage CKD (17-19).

Therefore based on the rational above and to the lack of relevant clinical data, the optimal P2Y12-ADP receptor antagonist for patients with stage 4 and 5 and patients undergoing chronic dialysis remains undetermined in ACS treated with PCI.

We aimed to compare the clinical efficacy ticagrelor and clopidogrel in patients with stage 4 and 5 or on chronic hemodialysis undergoing PCI for ACS.

Publications & conference data

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

1. Platelet biology and function: plaque erosion vs. rupture.
   Baaten CCFMJ, Nagy M, Bergmeier W, Spronk HMH, et al · · 2024 · cited 70× · PMID 37940193 · DOI 10.1093/eurheartj/ehad720
2. Platelet Abnormalities in CKD and Their Implications for Antiplatelet Therapy.
   Baaten CCFMJ, Schröer JR, Floege J, Marx N, et al · · 2022 · cited 62× · PMID 34750169 · DOI 10.2215/cjn.04100321
3. TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.
   Laine M, Lemesle G, Burtey S, Cayla G, et al · · 2020 · cited 14× · PMID 32473355 · DOI 10.1016/j.ahj.2020.04.013
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
5. Safety and Efficacy of Ticagrelor versus Clopidogrel in East Asian Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention Treated with Dual Antiplatelet Therapy: A Meta-Analysis of Randomized Controlled Trials.
   Li J, Wang Q, Wu C, Qu X, et al · · 2023 · cited 5× · PMID 37094558 · DOI 10.1159/000530602