Pharmacodynamic comparison of thienopyridine loading strategies in patients undergoing elective coronary stenting

Pharmacodynamic comparison of thienopyridine loading strategies in patients undergoing elective coronary stenting - ExcelsiorLOAD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006102

Enrollment

300

Registered

2014-05-21

Start date

2014-06-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25

Interventions

Group 1: Efient (Prasugrel), 60mg oral loading dose, (tablet), single dose Group 2: Efient (Prasugrel), 30mg oral loading dose, (tablet), single dose Group 3: Plavix (Clopidogrel), 600mg oral loading

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Stable patients with obstructive coronary heart disease and planned coronary stent implantation. Pretreatment with aspirin (100mg daily or loading dose of 400mg before coronary angiography). Age >= 18 years. Written informed consent.

Exclusion criteria

Exclusion criteria: Acute myocardial infarction Treatment with ticagrelor, prasugrel, fibrinolysis, or GP IIb/IIIa inhibitor within 7 days before enrollment. Contraindication for treatment with aspirin, clopidogrel, or prasugrel (in particular: active bleeding, history of stroke or TIA). Current oral anticoagulation. Severe thrombocytopenia (< 50.000/µl). Known severe disorder of the coagulation system. Participation in another drug trial. Pregnancy or lactation. Persons with a state of dependence with sponsor or investigator. Commitment to an institution. Dementia or other psychatric disorder (e.g., drug abuse) that prevents sufficient informed consent.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with ADP-induced platelet aggregation < 468 AU x min tested 1 hour following loading dose	—

Secondary

Measure	Time frame
Absolute ADP-induced platelet aggregation tested 0.5, 1.0, 1.5, 2.0, and 3.0 hours and day 1 following loading dose Proportion of patients with ADP-induced platelet aggregation 188 and < 468 AU x min tested 1, 2, 3 hours and day 1 following loading dose Ischemic and bleeding events within 4 weeks after inclusion (death, myocardial infarction, revascularization, stroke, bleeding according to BARC Criteria).	—

Measure

Time frame

Absolute ADP-induced platelet aggregation tested 0.5, 1.0, 1.5, 2.0, and 3.0 hours and day 1 following loading dose Proportion of patients with ADP-induced platelet aggregation 188 and < 468 AU x min tested 1, 2, 3 hours and day 1 following loading dose Ischemic and bleeding events within 4 weeks after inclusion (death, myocardial infarction, revascularization, stroke, bleeding according to BARC Criteria).

—

Countries

Germany

Contacts

Public ContactWillibald Hochholzer

Universitäts-Herzzentrum Freiburg Bad KrozingenKlinik für Kardiologie und Angiologie II

willibald.hochholzer@universitaets-herzzentrum.de+49 7633 402-4285

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026