PRETREATMENT WITH HIGH DOSE CLOPIDOGREL FOR REDUCTION OF THROMBOTIC EVENTS AFTER ELECTIVE CORONARY TERRITORY STENTING WITH DRUG ELUTING STENTS: ThePROTECTED Study - The PROTECTED Study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000517-19-GB

Enrollment

100

Registered

2005-10-13

Start date

2005-11-23

Completion date

Unknown

Last updated

2012-05-01

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

Conditions

PERCUTANEOUS CORONARY INTERVENTION( USING DRUG ELUTING STENTS)

Interventions

Trade Name: PLAVIX 75mg or Clopidogrel 75mg Pharmaceutical Form: Other descriptive name: clopidogrel bisulfate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 97.8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive patients suitable for elective coronary stenting using Drug eluting stents will be eligible and recruited for the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria will be history of bleeding diathesis, acute myocardial infarction or acute coronary syndrome/troponin elevation within 14 days, stroke within 3 months, drug or alcohol abuse, pro-thrombin time >1.5 times control, platelet count 4.0mg/dl, or previous use of theinopyridines or GP IIb/IIIa inhibitors

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Inhibition of platelet aggregation (platelet activation), and thereby reduction in thrombosis related ischemic events(troponin I elevation) after elective coronary stenting with Drug eluting stents. ;Main Objective: Primary outcome measure Higher dose clopidogrel loading (600mg) has the same efficacy and rapidity as 300mg clopidogrel loading + GP IIb/IIIa inhibitor (Reopro) infusion in achieving inhibition of platelet aggregation(platelet activation),and thereby reducing thrombosis related ischemic events after elective coronary stenting with Drug eluting stents. ;Secondary Objective: The secondary outcome measures are (a) 24-hour and 30 days MACE (MI/TLR/DEATH) (b) Reduction in peri-procedural troponin release (as a marker of myocardial necrosis) (c) P2Y12 receptor polymorphism (as a cause for non-response) (d) To determine the optimum maintenance dose of clopidogrel to achieve maximum inhibition of platelet aggregation after stenting with drug eluting stents	—

Measure

Time frame

Primary end point(s): Inhibition of platelet aggregation (platelet activation), and thereby reduction in thrombosis related ischemic events(troponin I elevation) after elective coronary stenting with Drug eluting stents. ;Main Objective: Primary outcome measure Higher dose clopidogrel loading (600mg) has the same efficacy and rapidity as 300mg clopidogrel loading + GP IIb/IIIa inhibitor (Reopro) infusion in achieving inhibition of platelet aggregation(platelet activation),and thereby reducing thrombosis related ischemic events after elective coronary stenting with Drug eluting stents. ;Secondary Objective: The secondary outcome measures are (a) 24-hour and 30 days MACE (MI/TLR/DEATH) (b) Reduction in peri-procedural troponin release (as a marker of myocardial necrosis) (c) P2Y12 receptor polymorphism (as a cause for non-response) (d) To determine the optimum maintenance dose of clopidogrel to achieve maximum inhibition of platelet aggregation after stenting with drug eluting stents

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Countries

United Kingdom

Outcome results

None listed

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