Bedside Genetic or Pharmacodynamic Testing to Prevent Periprocedural Myonecrosis During PCI (ONSIDE TEST)

Stable Angina Clinical Trial

— ONSIDE TEST  

Official title:

Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930773
• Other study ID #: ONSIDE TEST
• Secondary ID: Klub 30, 2012
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: September 2019

Study information

• Verified date: December 2018
• Source: Medical University of Warsaw
• Contact: Lukasz Koltowski, MD, PhD
• Email: lukasz[@]koltowski.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75

• elective PCI

Exclusion Criteria:

• acute coronary syndrome (troponin > 1 x ULN),

• administration of glycoprotein IIb/IIIa inhibitors,

• chronic total occlusion,

• lesions with extensive calcifications requiring rotational atherectomy,

• platelet count <70 000 /µl

• high bleeding risk,

• coronary bypass surgery in the previous 3 months,

• severe chronic renal failure (eGFR < 30 mL/min)

• requirement for warfarin, dabigatran, apixaban, rivaroxaban

• history of stroke or TIA,

• weight < 60 kg

• known bleeding diathesis,

• hematocrit of < 30% or >52%

• pregnancy

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Device:
• Genotyping
Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
• Phenotyping
Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.

Locations

Country	Name	City	State
Hungary	Heart Center Balatonfüred	Balatonfüred
Poland	1st Department of Cardiology, Medical University of Warsaw	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Warsaw	Polish Cardiac Society, University of Pecs

Countries where clinical trial is conducted

Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peak troponin elevation	The level of peak troponin-I elevation during 24 hours of elective PCI	Within 24 hours of PCI
Other	Proportion of patients with peri-procedural MI	The rate of peri-procedural MI defined as a peak troponin-I value greater than 5x the ULN within 24 hours.	Within 24 hours of PCI
Other	BARC type 3 and 5 bleeding	BARC-defined type 3 (clinical, laboratory, and/or imaging evidence of bleeding, with healthcare provider responses) and type 5 (fatal) bleeds happening within 7 days of PCI.	Within 1 week of PCI
Other	Death, MI, stent thrombosis (ST) or urgent repeat revascularization	The rate of cardiac death, myocardial infarction, definite or probable stent thrombosis or urgent repeat revascularization within 30 days of elective PCI.	30 days after PCI
Primary	Prevalence of periprocedural myocardial injury within 24 h after PCI	Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI	Within 24 hours after Percutaneous Coronary Intervention (PCI)
Secondary	Proportion of patients having periprocedural myocardial infarction (MI)	Periprocedural MI is defined as a CK-MB elevation greater than 3x of the upper limit of norm (ULN) within 24 hours of elective PCI.	Within 24 hours or PCI