Fact CheckerSign in

NCT03783351Active, not recruiting

Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE)

CYP2C19 Genotype-GUided Dual Antiplatelet theRapy in pAtieNts Treated With New Generation Drug Eluting stEnts (the GUARANTEE Study)

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

The aim of this study is to assess the efficacy and safety of the CYP2C19 genotype guided antiplatelet treatment strategy, using clopidogrel in non-carriers of a CYP2C19\*2 or \*3 allele and ticagrelor in carriers of a CYP2C19\*2 or \*3 allele in patients treated with new generation drug eluting stents.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
4009 (actual)
First submitted
11 Dec 2018
Start date
27 May 2019
Primary completion date
Mar 2026
Lead sponsor
Beijing Anzhen Hospital
NCT number
NCT03783351

What you commit to

  • Study type: Interventional
  • Participants enrolled: 4009
  • From 27 May 2019 to the primary completion date, Mar 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient having received thrombolytic therapy within the previous 24 hours
  • Patient is receiving chronic oral anticoagulation therapy (i.e., vitamin K antagonist, direct thrombin inhibitor, Factor Xa inhibitor)

Other illness

  • Patient developing procedure-related complications such as stent thrombosis, coronary dissection, coronary perforation, cardiac tamponade or no-reflow during PCI
  • Contraindicated or allergic to clopidogrel or ticagrelor
  • History of intracranial hemorrhage
  • Patient has a history of bleeding diathesis or coagulopathy
  • Patient has an active pathological bleeding, such as active gastrointestinal (GI) bleeding
  • Patient with active liver diseases
  • Patient has a malignancy or a life expectancy of less than one year

Lab values

  • Patient unable to receive 12 months of dual anti-platelet therapy
  • Anticipated discontinuation of dual anti-platelet therapy within the 12-month follow-up period, example for elective surgery
  • Patient with LVEF \<30%
  • Patient with severe renal insufficiency (eGFR \<30ml/min/1.73m2 based on simplified MDRD equation or CrCl \<30ml/min based on Cockcroft-Gault equation)
  • Platelet count \<100 000/μL, or hematocrit \<32% or \>52%, or white blood cell count \<3000/μL

Other

  • Patient or physician refusal to enroll in the study
  • Physician has known the patient's CYP2C19 genotype
  • Patient is pregnant, breastfeeding, or planning to become pregnant within 12 months
  • Patient with cardiogenic shock or mechanical circulatory assist devices placed

Who the study is looking for

  • Patient ≥18 years of age
  • Patient presents with acute coronary syndrome (ACS) or stable coronary artery disease (SCAD)
  • Patient has a percutaneous coronary intervention (PCI) indication and the new generation drug eluting stent(s) is successfully implanted

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing ChaoYang Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Tsinghua Changgung Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Friendship Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Fuwai Hospital Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Tong Ren Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Anzhen Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
China-Japan Friendship Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Luhe Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.