High on-Clopidogrel Platelet Reactivity in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention – a pilot study

High on-Clopidogrel Platelet Reactivity in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention – a pilot study - HPR-AF PCI Pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021212

Enrollment

158

Registered

2020-07-07

Start date

2020-05-17

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

Coronary artery disease Atrial fibrillation, Heart attack, Stroke, Thromboembolic event, Stent thrombosis I21 I25 I26 I48 I63

Interventions

Group 1: • Group A: high on-clopidogrel platelet reactivity defined as a value of =46U or Group 2: • Group B: no high on-clopidogrel platelet reactivity defined as a value of <46U.

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Key inclusion criteria: - Informed consent - =18 years of age or older - Atrial fibrillation with an indication for oral anticoagulation (i.e. CHA2DS2VASC score =1 for males, =2 for females) - Percutaneous coronary intervention in the first 3 Days

Exclusion criteria

Exclusion criteria: Key exclusion criteria: - Contraindication to a NOAC (i.e. Apixaban, Dabigatran, Edoxaban, Rivaroxaban) or Clopidogrel - History of stent-thrombosis - Uncompliant patient from the point of view of the principal investigator like f.ex.: malcompliance, very often use of alcohol and drugs or not willing to proceed according to the protocoll (Patient willing not to be follow-uped). -GPIIb/IIa inhibition in the last 24h -Use of Prasugrel or Ticagrelor in the last 7 days

Design outcomes

Primary

Measure	Time frame
Primary outcome: •Composite of all-cause death, myocardial infarction, or stroke at 6 months. What will be evaluated is the influence of high Platelet activation under Clopidogrel with ischemic events in Patients with atrial Fibrillation where a new new stent was implanted and as a consequence there is indication to oral anticoagulation and Clopidorgel.	—

Secondary

Measure	Time frame
Key secondary outcomes: • Major or clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) at 6 months. Evaluation of association of other explorative markers with the ischemic and bleeding outcomes: -ADP/TRAP-induced Platelet Aggregation -Thromboelastography -CYP2C19 genotyping -Immature platelet fraction -Antiphospholipid antibodies	—

Countries

Germany

Contacts

Public ContactDiona Gjermeni

Karidologie und Angiologie

diona.gjermeni@uniklinik-freiburg.de0004976127034010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026