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. 2017 Dec 14;2017(12):CD005158. doi: 10.1002/14651858.CD005158.pub4

MIRROR 2012.

Methods Randomized controlled trial.
Participants 80 people with peripheral arterial disease which required PTA alone or PTA with additional stenting of the femoropopliteal lesion if required. Stents used if clinically indicated after primary PTA either because of stenosis of > 30% after primary PTA or because of flow‐limiting dissection after primary PTA. All used stents were Nitinol stents.
Interventions Clopidogrel plus aspirin (n = 40; mean age (± SD) 69.8 ± 8.8 years, male 19, female 21) for 6 months.
Placebo plus aspirin (n = 40; mean age (± SD) 70.2 ± 11.4 years, male 23, female 17) for 6 months.
Outcomes Primary: concentration of platelet activation markers using the Chandler‐Loop vessel model.
Secondary: clinical development of the participants 6 months after the intervention including TLR, restenosis, ankle‐brachial index, Rutherford class, serious adverse events and days in hospital because of TLR.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "... they were randomised to one of the two treatment groups according to a lot‐generated random list ..."
Allocation concealment (selection bias) Unclear risk No description.
Blinding (performance bias and detection bias) 
 All outcomes Low risk " ... Medication was given in the form of blister packs to the patients; true and placebo medication was indistinguishable. The patients were supplied with the blinded medication for the whole duration of the trial. The patients and investigators were not informed about the assigned study medication..."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants were analysed.
Selective reporting (reporting bias) Low risk Reported as per protocol.
Other bias Low risk Investigator‐initiated study supported by a pharmaceutical company. "...The sponsors had no involvement in the design of the trial, collection and analysis of the data, or writing of the report..."